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| ID | Type | Description | Link |
|---|---|---|---|
| SU-03082011-7559 | Other Identifier | Stanford University | |
| SARCOMA0007 | Other Identifier | OnCore |
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Study did not reach primary objective; study did not accrue enough patients.
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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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The outcome of patients with metastatic Ewings Sarcoma is poor with current standard of care chemotherapy, with less than 30% survival. Based on recent encouraging pediatric literature we have designed this trial to improve the outcome of patients with metastatic Ewings sarcoma using Irinotecan and Temozolomide in addition to standard chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Therapy | Experimental | Regimen A alternating with Regimen B every 21 days Regimen A:
Regimen B:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan | Drug | 50 mg/m2/day x 5 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (Partial and Complete Response) | Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for up to 2 years (24 months) or until progression of disease or initiation of new anticancer therapy. Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen N. Ganjoo | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combination Therapy | Regimen A alternate with Regimen B every 21 days Regimen A: Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose) Regimen B: Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period. Irinotecan: 50 mg/m2/day x 5 days Vincristine: 2 mg/m2 (capped at 2mg total do) Temozolomide: 100 mg/m2/day x 5 days Doxorubicin: 75 mg/m2 Cytoxan: 1200 mg/m2 Pegfilgrastim: 6 mg Mesna: 240 mg/m2 in 50 ml NS |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Combination Therapy | Regimen A alternate with Regimen B every 21 days Regimen A: Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose) Regimen B: Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period. Irinotecan: 50 mg/m2/day x 5 days Vincristine: 2 mg/m2 (capped at 2mg total do) Temozolomide: 100 mg/m2/day x 5 days Doxorubicin: 75 mg/m2 Cytoxan: 1200 mg/m2 Pegfilgrastim: 6 mg Mesna: 240 mg/m2 in 50 ml NS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (Partial and Complete Response) | Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for up to 2 years (24 months) or until progression of disease or initiation of new anticancer therapy. Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. | Posted | Count of Participants | Participants | Up to 24 months |
|
All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported.
Patients were asked about adverse events at every clinic visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combination Therapy | Regimen A alternate with Regimen B every 21 days Regimen A: Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose) Regimen B: Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period. Irinotecan: 50 mg/m2/day x 5 days Vincristine: 2 mg/m2 (capped at 2mg total do) Temozolomide: 100 mg/m2/day x 5 days Doxorubicin: 75 mg/m2 Cytoxan: 1200 mg/m2 Pegfilgrastim: 6 mg Mesna: 240 mg/m2 in 50 ml NS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intermittent headache G1 | General disorders | CTCAE (4.0) | Systematic Assessment |
Study did not reach primary objective; study didn't accrue enough patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen Ganjoo, MD | Stanford University Medical Center | 650-725-6413 | kganjoo@stanford.edu |
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| D012512 | Sarcoma, Ewing |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D014750 | Vincristine |
| D000077204 | Temozolomide |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| C455861 | pegfilgrastim |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D014748 | Vinca Alkaloids |
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| Vincristine | Drug | 2 mg/m2 to a maximum of 2 mg |
|
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| Temozolomide | Drug | 100 mg/m2/day x 5 days followed by 2 weeks treatment-free |
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| Doxorubicin | Drug | Starting dose 75 mg/m2 to a maximum of 450mg/m2 |
|
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| Cytoxan | Drug | 1200 mg/m2 |
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| Pegfilgrastim | Drug | 6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle |
|
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Secondary | Progression-free Survival (PFS) | The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment. | All study participants were lost to follow-up after completion of active treatment and collection of response rate, ie, within 2 years of the treatment conclusion but before documented progression. No data. | Posted | 24 months |
|
|
| 1 |
| 3 |
| 3 |
| 3 |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dehydration | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Decreased energy G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Insomnia G1 | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Insomnia G2 | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fever G1 | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Hiccups G1 | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Throat pain G2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea, intermittent G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea, intermittent G2 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Mucositis oral G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Oral lesions G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| oral candidiasis G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Sore throat G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain with swallowing G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Worsening acid reflux G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal cramping G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Abdominal pain G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Intermittent diarrhea G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Vomiting G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Vomiting intermittent G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Constipation G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea and vomiting G1 | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Anemia G2 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Worsened anemia G2 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Anemia G3 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Decreased neutrophils G4 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Infection-staph epidermis bacteremia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Platelet count decreased G1 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypokalemia G1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypocalcemia intermittent G1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyponatremia intermittent G1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Platelet count decreased G2 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Platelet count decreased G4 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Intermittent hypoglycemia G1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| White blood cells decreased G2 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| White blood cells decreased G4 | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypomagnesemia G1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypokalemia G1 | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hip pain L G1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain sacrum (tailbone) G1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain left leg G1 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain-lowe leg, back G2 | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain generalized 2-3 days post neulasta G1 | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Tingling at left toes G1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Numbness on left shin G1 | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Cough G1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Onychomycosis G2 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Hip abscess G3 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Erythema L hip G2 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Erythema groin crease G1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Erythema left leg G1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Edema left leg pitting 2+, G1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperpigmentation left knee G1 | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Disc edema R eye G1 | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| Nasal congestion G1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Rhinorrhea G1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D012516 |
| Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D012509 | Sarcoma |
| D046948 |
| Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |