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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000066360 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-T98-0007 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with indolent lymphoma, Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia.
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study. Patients are stratified by disease (chronic lymphocytic leukemia vs indolent lymphoma vs Waldenstrom's macroglobulinemia).
All patients receive dolastatin 10 IV bolus every 3 weeks. Patients continue treatment until disease progression, unacceptable toxicity, or patient's withdrawal from the study.
PROJECTED ACCRUAL: A maximum of 74 patients will be accrued for this study over 15 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dolastatin 10 | Drug |
DISEASE CHARACTERISTICS:
Histologic or cytologic diagnosis of indolent lymphoma as defined by International Working Formulation categories A-C or diagnosis of Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia
Lymphoma must be stage III, IV, or recurrent (no primary CNS lymphoma or lymphomatous meningitis)
Waldenstrom's macroglobulinemia must have at least one of the following:
Chronic lymphocytic leukemia must be intermediate or high risk stages I-IV and have progressed on fludarabine therapy unless patient cannot tolerate fludarabine
Intermediate risk group must have at least one indication of active disease:
Intolerance, relapse, or failure following prior fludarabine allowed
Measurable or evaluable disease
No untreated immediate life threatening tumor complications
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Steven M. Grunberg, MD | University of Vermont | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland | 21201 | United States | ||
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D008258 | Waldenstrom Macroglobulinemia |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008224 | Lymphoma, Follicular |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C064570 | dolastatin 10 |
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| Barbara Ann Karmanos Cancer Institute |
| Detroit |
| Michigan |
| 48201-1379 |
| United States |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | 43210-1240 | United States |
| Vermont Cancer Center | Burlington | Vermont | 05401-3498 | United States |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |