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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00445 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Ortho Biotech, Inc. | INDUSTRY |
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The goal of this clinical research study is to learn if treatment with two types of chemotherapy combinations can help to control peripheral T-cell lymphoma.
All of the drugs used in this study are commonly used in the treatment of cancer. However, using these drugs in combination is investigational.
During treatment, you will be given two different cycles of chemotherapy, which will be alternated every 21 days.
For Cycle 1, cyclophosphamide will be given by vein two times a day on Days 1,2, and 3. Each dose will take around 3 hours to give. Mesna will be given by vein nonstop over Days 1 through 3. Pegylated liposomal doxorubicin will be given by vein over 1 hour on Day 2. Vincristine will be given by vein on Days 4 and 11. Dexamethasone will be given by mouth on Days 1 through 4 and 11 through 14. Other drugs will be given before, during, and after chemotherapy to help decrease the risk of developing side effects. These drugs may be given by mouth or by injection.
For Cycle 2, methotrexate will be given by vein over 2 hours on Day 1 and over 22 hours on day 1. Cytarabine will be given by vein twice a day on Days 2 and 3. Each dose will take about 2 hours to give. Other drugs will be given before, during, and after treatment to help decrease the risk of developing side effects. These drugs may be given by mouth or by injection.
To help increase the blood counts and help decrease the risk of developing infections, your doctor may decide that treatment with filgrastim is necessary. Filgrastim may be given as once-a-day injections under the skin starting 24 hours after the end of Day 4 vincristine (Cycle 1) and starting 24 hours after the end of Cytarabine (Cycle 2). Your blood counts will be monitored and filgrastim is stopped when the levels become normal.
Cycles 1 and 2 will be alternated every 21 days. Both Cycles 1 and 2 can be given on an outpatient basis if your physician authorizes it. However, if your serum creatinine (blood test) reaches a certain level, Cycle 2 should be given on an inpatient basis.
Depending on how the disease responds, treatment may be stopped after 2,4, or 6 cycles. However, treatment may continue for up to 8 cycles.
During treatment, you will have around 2-3 tablespoons of blood collected at least once a week for routine tests.
After every 2 cycles, tumors will be measured using x-rays or other scans (CT, MRI, etc.) and bone marrow samples will be taken. Heart scans or heart function tests may also be needed if you doctor feels it is necessary.
If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
After the last cycle of chemotherapy, you will have follow-up exams scheduled. During these exams, you will have a chest x-ray and CT scans of the chest, abdomen (stomach) and pelvis (waist area), and PET scan. You will have blood collected (2-3 tablespoons) for routine tests. If your doctor feels it is necessary, you may also have a sample of bone marrow collected. You may choose to have long-term follow-up exams at M. D. Anderson or with your local physician.
This is an investigational study. All of the study drugs are approved by the FDA for cancer treatment and are commercially available. However, the use of the drugs in combination is experimental. Up to 55 participants will take part in this study. All will be enrolled at M. D. Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCVIDDOXIL Regimen | Experimental | Cycle 1: Cyclophosphamide by vein two times a day on Days 1,2, and 3. Mesna by vein nonstop over Days 1 through 3. Pegylated liposomal doxorubicin by vein over 1 hour on Day 2. Vincristine by vein on Days 4 and 11. Dexamethasone by mouth on Days 1 through 4 and 11 through 14. Cycle 2: Methotrexate by vein over 2 hours on Day 1 and over 22 hours on day 1. Cytarabine by vein twice a day on Days 2 and 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Cycle 1: 300 mg/m^2 by vein Over 3 Hours Twice Daily on Days 1, 2, and 3. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3 Year Progression-Free Survival Rate | Percentage of participants out of total treated alive with disease progression 3 years following registration. Progression-free survival (PFS) was measured from the date of study registration to the date of documented disease progression or death of any cause. | From registration to disease progression or death, up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasuhiro Oki, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26260306 | Result | Chihara D, Pro B, Loghavi S, Miranda RN, Medeiros LJ, Fanale MA, Hagemeister FB, Fayad LE, Romaguera JE, Samaniego F, Neelapu SS, Younes A, Fowler NH, Rodriguez MA, Wang M, Kwak LW, McLaughlin P, Dang NH, Oki Y. Phase II study of HCVIDD/MA in patients with newly diagnosed peripheral T-cell lymphoma. Br J Haematol. 2015 Nov;171(4):509-16. doi: 10.1111/bjh.13628. Epub 2015 Aug 10. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Of the 55 participants registered, two participants were found not to be eligible prior to start of study therefore are excluded from trial details.
Recruitment period: September 17, 2003 to May 8, 2009. All recruitment done at The University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | HCVIDDOXIL Regimen | Cycle 1: Cyclophosphamide 300 mg/m^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m^2 continuous IV Days 1-3. Doxil 25 mg/m^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14. Cycle 2: Methotrexate 200 mg/m^2 over 2 hours on Day 1 and 800 mg/m^2 over 22 hours on day 1. Cytarabine 3 Gm/m^2 IV twice a day on Days 2 and 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HCVIDDOXIL Regimen | Cycle 1: Cyclophosphamide 300 mg/m^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m^2 continuous IV Days 1-3. Doxil 25 mg/m^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14. Cycle 2: Methotrexate 200 mg/m^2 over 2 hours on Day 1 and 800 mg/m^2 over 22 hours on day 1. Cytarabine 3 Gm/m^2 IV twice a day on Days 2 and 3. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 3 Year Progression-Free Survival Rate | Percentage of participants out of total treated alive with disease progression 3 years following registration. Progression-free survival (PFS) was measured from the date of study registration to the date of documented disease progression or death of any cause. | Of the 53 participants, *6 participants* were not evaluable for response due to either no measurable disease (1) or early departure from study for adverse events (5) | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to disease progression or death, up to 3 years |
|
Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
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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 | HCVIDDOXIL Regimen | Cycle 1: Cyclophosphamide 300 mg/m^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m^2 continuous IV Days 1-3. Doxil 25 mg/m^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14. Cycle 2: Methotrexate 200 mg/m^2 over 2 hours on Day 1 and 800 mg/m^2 over 22 hours on day 1. Cytarabine 3 Gm/m^2 IV twice a day on Days 2 and 3. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| massive cytomegalovirus infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Flowers/Chair, Lymphoma-Myeloma | The University of Texas (UT) MD Anderson Cancer Center | 713-745-6095 | crflowers@mdanderson.org |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D015080 | Mesna |
| D014750 | Vincristine |
| D008727 | Methotrexate |
| D003561 | Cytarabine |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| C506643 | liposomal doxorubicin |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Mesna | Drug | Cycle 1: 600 mg/m^2 by vein Continuous Infusion Over Days 1, 2, and 3. |
|
| Vincristine | Drug | Cycle 1: 1.4 mg/m^2 by vein On Day 4 and 11. |
|
| Methotrexate | Drug | Cycle 1 and 2: 200 mg/m^2 by vein Over 2 Hours on Day 1, followed by 800 mg/m^2 IV Over 22 Hours on Day 1. |
|
| Ara-C | Drug | Cycle 1 and 2: 3 Gm/m^2 Over 2 Hours Twice Daily On Days 2 and 3. |
|
|
| Dexamethasone | Drug | Cycle 1: 40 mg by vein or by mouth daily on Days 1-4 and 11-14. |
|
|
| G-CSF | Drug | Cycle 1 and 2: 300 or 480 mcg subcutaneously 24 hours after end of Day 4 vincristine. |
|
|
| Doxil | Drug | Cycle 1: 25 mg/m^2 by vein Over 1 Hour on Day 2. |
|
|
| Non-Compliance |
|
| Congestive Heart Failure |
|
| Transplant in CR |
|
| Unrelated Infection/Death |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 1 |
| 53 |
| 46 |
| 53 |
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infectious Disease | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Liver Toxicities | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |