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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA008748 | U.S. NIH Grant/Contract | View source | |
| MSKCC-06065 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of Rochester | OTHER |
| The Cleveland Clinic | OTHER |
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works in treating patients with T-cell or natural killer-cell lymphoma that has relapsed or not responded to previous treatment.
OBJECTIVES:
Primary
OUTLINE: This is a phase I, non-randomized, dose-escalation study followed by an open-label, phase II study.
Cohorts of 1-6 patients receive escalating doses of clofarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clofarabine | Experimental | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clofarabine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | 2 years | |
| Response Rate for Participants With Non-Hodgkin's Lymphoma | Response rate as defined by complete remission, complete remission unconfirmed, partial remission, positron emission tomography (PET)-negative partial remission, stable disease, and progressive disease (Phase II) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Evaluated for Toxicity | Toxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0 | 2 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed T-cell or natural killer (NK)-cell lymphoma, including any of the following subtypes:
Relapsed or refractory disease, meeting both of the following criteria:
Must have been treated with prior cytotoxic chemotherapy and/or monoclonal antibody therapy
No standard curative treatment exists
Evaluable disease (Phase I)
Measurable disease, defined as any nodal site or mass lesion ≥ 1.5 cm in longest transverse diameter on physical exam or CT scan OR a measurable extranodal site > 1 cm (Phase II)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
At least 3 weeks since prior therapy, including any of the following:
Concurrent stable-dose corticosteroids allowed
No colony-stimulating factor therapy during the first course of study therapy
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| Name | Affiliation | Role |
|---|---|---|
| Steven M. Horwitz, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States | ||
| James P. Wilmot Cancer Center at University of Rochester Medical Center |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 4 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. |
| FG001 | 8 mg/m2/Day Clofarabine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 26, 2008 |
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| Rochester |
| New York |
| 14642 |
| United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. |
| FG002 | 13.2 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. |
| FG003 | 20 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. |
| FG004 | 28 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. |
| BG001 | 8 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. |
| BG002 | 13.2 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. |
| BG003 | 20 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. |
| BG004 | 28 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Maximum Tolerated Dose | Posted | Number | mg/m2 of clofarabine | 2 years |
|
|
| ||||||||||||||||||||||||||||
| Primary | Response Rate for Participants With Non-Hodgkin's Lymphoma | Response rate as defined by complete remission, complete remission unconfirmed, partial remission, positron emission tomography (PET)-negative partial remission, stable disease, and progressive disease (Phase II) | Evaluable participants with Non-Hodgkin's Lymphoma | Posted | Count of Participants | Participants | 2 years |
| ||||||||||||||||||||||||||||
| Secondary | Participants Evaluated for Toxicity | Toxicity as defined by NCI Common Terminology Criteria for Adverse Events v 3.0 | Posted | Count of Participants | Participants | 2 years |
|
2 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 | 4 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. | 1 | 1 | 0 | 1 | 1 | 1 |
| EG001 | 8 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. | 3 | 3 | 1 | 3 | 3 | 3 |
| EG002 | 13.2 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. | 3 | 4 | 1 | 4 | 4 | 4 |
| EG003 | 20 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. | 12 | 17 | 13 | 17 | 17 | 17 |
| EG004 | 28 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. | 4 | 4 | 4 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Calcium, high (hypercalcemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Creatinine | Investigations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Fever (in the absence of neutropenia) | General disorders | Systematic Assessment |
| ||
| Glucose, low (hypoglycemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hemorrhage/Bleeding, other | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Inf norm ANC/gr1/2 neut-Bronchitis NOS | Infections and infestations | Systematic Assessment |
| ||
| Inf norm ANC/gr1/2 neut-Joint | Infections and infestations | Systematic Assessment |
| ||
| Inf unknown ANC-Cellulitis(skin) | Infections and infestations | Systematic Assessment |
| ||
| Inf unknown ANC-Pneumonia(lung) | Infections and infestations | Systematic Assessment |
| ||
| Infection w/ Gr 3/4 neut, Blood | Infections and infestations | Systematic Assessment |
| ||
| Infection, other | Infections and infestations | Systematic Assessment |
| ||
| Mucositis (Clin exam)- Oral cavity | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neutrophils/granulocytes (ANC/AGC) | Investigations | Systematic Assessment |
| ||
| Ocular/Visual - Other (specify) | Eye disorders | Systematic Assessment |
| ||
| Odor (patient odor) | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pain - Other (specify) | General disorders | Systematic Assessment |
| ||
| Pain - Throat/pharynx/larynx | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Platelets | Investigations | Systematic Assessment |
| ||
| Pleural effusion (non-malig) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rigors/chills | General disorders | Systematic Assessment |
| ||
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Uric acid, high (hyperuricemia) | Metabolism and nutrition disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue (asthenia, lethargy, malaise) | General disorders | Systematic Assessment |
| ||
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hemoglobin | Investigations | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pain - Other (specify) | General disorders | Systematic Assessment |
| ||
| Pain - Throat/pharynx/larynx | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Constipation | General disorders | Systematic Assessment |
| ||
| Creatinine | Investigations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Infection, other | Infections and infestations | Systematic Assessment |
| ||
| Leukocytes (total WBC) | Investigations | Systematic Assessment |
| ||
| Neutrophils/granulocytes (ANC/AGC) | Investigations | Systematic Assessment |
| ||
| Pain - Oral cavity | Gastrointestinal disorders | Systematic Assessment |
| ||
| Platelets | Investigations | Systematic Assessment |
| ||
| Pleural effusion (non-malig) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulm/upp respiratory - Other (spec) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Weight loss | Investigations | Systematic Assessment |
| ||
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| ALT, SGPT | Investigations | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| AST, SGOT | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Bilirubin (hyperbilirubinemia) | Investigations | Systematic Assessment |
| ||
| Calcium, high (hypercalcemia) | Investigations | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dermatology/Skin, other | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Edema: Limb | General disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Infection w/ Gr 3/4 neut, Skin (cellulites) | Infections and infestations | Systematic Assessment |
| ||
| INR | Investigations | Systematic Assessment |
| ||
| Lymphopenia | Investigations | Systematic Assessment |
| ||
| Magnesium, high (hypermagnesemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Magnesium, low (hypomagnesemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Mucositis (Clin exam)- Oral cavity | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ophthalmoplegia/diplopia (double vision) | Eye disorders | Systematic Assessment |
| ||
| Pain - Back | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain - Bone | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain - Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Potassium, high (hyperkalemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Rash/desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rigors/chills | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Horowitz MD | Memorial Sloan Kettering Cancer Center | 646-608-2680 | horwitzs@mskcc.org |
| Jan 7, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D007119 | Immunoblastic Lymphadenopathy |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D015463 | Leukemia, Prolymphocytic |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D000072281 | Lymphadenopathy |
| D007945 | Leukemia, Lymphoid |
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| ID | Term |
|---|---|
| D000077866 | Clofarabine |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 20 mg/m2/day and will be escalated to higher dose levels. |
| OG004 | 28 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 28 mg/m2/day and will be escalated to higher dose levels. |
|
|
| OG004 | 28 mg/m2/Day Clofarabine | Patients will receive intravenous clofarabine once daily for three consecutive days. Doses of clofarabine will start at 4 mg/m2/day and will be escalated to higher dose levels. |
|
|