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Phase II Trial of Dolastin 10 in Indolent Lymphoma and Chronic Lymphocytic Leukemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma

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Trial Information

Phase II Trial of Dolastin 10 in Indolent Lymphoma and Chronic Lymphocytic Leukemia


OBJECTIVES:

- Estimate the efficacy of dolastatin 10 in patients with indolent lymphoma,
Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia.

- Evaluate the qualitative and quantitative toxicities of dolastatin 10 in this patient
population.

- Investigate the mechanism of action of dolastatin 10 in regards to apoptosis and
effects of microtubules.

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.

Inclusion Criteria


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:

- IGM greater than 3,000 mg/dL

- Hemoglobin less than 10.0 g/dL

- Bone marrow involvement greater than 30% lymphocytes

- At least 2 cm lymphadenopathy

- Serum viscosity greater than 3.0

- 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:

- Presence of any one of the disease related B symptoms: 10% or more loss of
body weight over the preceding 6 month period, extreme fatigue, fever above
100 degrees F without evidence of infection, or night sweats

- Massive (greater than 6 cm below left costal margin) or progressive
splenomegaly

- Massive (greater than 10 cm in longest diameter) or progressive
lymphadenopathy

- Progressive lymphocytosis with an increase of 50% over a 2 month period or
anticipated doubling time of less than 12 months

- Evidence of progressive marrow failure as manifested by the development or
worsening of anemia and/or thrombocytopenia

- Autoimmune anemia and/or thrombocytopenia poorly responsive to
corticosteroid therapy

- Intolerance, relapse, or failure following prior fludarabine allowed

- Measurable or evaluable disease

- No untreated immediate life threatening tumor complications

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- CALGB 0-2

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

- WBC at least 4,000/mm^3*

- Absolute granulocyte count at least 1,500/mm^3*

- Platelet count at least 100,000/mm^3*

- Hemoglobin at least 9 g/dL* NOTE: *Unless documented bone marrow involvement

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 2.5 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Other:

- No prior malignancy except adequately treated basal or squamous cell skin cancer,
carcinoma in situ of the cervix, well differentiated stage IA prostate cancer, or any
other cancer from which the patient has been disease free for five years

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior autologous bone marrow or stem cell transplantation

Chemotherapy:

- See Disease Characteristics

- No more than 2 prior systemic regimens for treatment of lymphoma

- No chemotherapy for treatment of any other prior malignancy

- At least 4 weeks since chemotherapy and recovered

- Prior fludarabine therapy allowed

Endocrine therapy:

- See Disease Characteristics

Radiotherapy:

- Prior radiotherapy allowed (index lesion cannot be within prior radiotherapy field)

Surgery:

- Recovered from prior surgery

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Steven M. Grunberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Vermont

Authority:

United States: Federal Government

Study ID:

VCC-9802

NCT ID:

NCT00005579

Start Date:

June 1998

Completion Date:

February 2003

Related Keywords:

  • Leukemia
  • Lymphoma
  • Waldenström macroglobulinemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Vermont Cancer CenterBurlington, Vermont  05401-3498
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595