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PHASE II CLINICAL EVALUATION OF BRYOSTATIN 1 IN PATIENTS WITH RELAPSED NON-HODGKIN'S LYMPHOMA AND CLL


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

Thank you

Trial Information

PHASE II CLINICAL EVALUATION OF BRYOSTATIN 1 IN PATIENTS WITH RELAPSED NON-HODGKIN'S LYMPHOMA AND CLL


OBJECTIVES: I. Assess the efficacy of bryostatin 1 administered as a 72-hour infusion in
patients with relapsed non-Hodgkin's lymphoma and chronic lymphocytic leukemia. II. Gain
information regarding the toxicity and tolerability of escalated vincristine doses given
after each bryostatin 1 infusion in cohorts of patients who fail to respond to bryostatin
alone. III. Determine the qualitative and quantitative toxic effects of bryostatin 1 in
these patients. IV. Determine the duration of response and survival following treatment with
bryostatin 1.

OUTLINE: All patients receive bryostatin 1 by 72-hour continuous infusion every 2 weeks
until disease progression or until 2 courses beyond documentation of complete remission.
Response is assessed after every 4 courses. Patients with disease progression who continue
to meet the eligibility criteria receive vincristine within 2 hours after completion of each
bryostatin 1 infusion. Groups of 3-6 patients receive escalated doses of vincristine until
the maximum tolerated dose with bryostatin 1 is determined. Courses repeat every 2 weeks, as
above; no individual dose escalation is allowed. No concurrent steroids are permitted.
Patients are followed for survival.

PROJECTED ACCRUAL: A total of 25 evaluable patients with low-grade NHL or CLL will be
entered over approximately 20 months if there are 2-4 responses in the first 15 patients. A
total of 20 evaluable patients with intermediate- or high-grade NHL will be entered over
approximately 2 years if there are 1 or 2 responses in the first 10 patients.

Inclusion Criteria


DISEASE CHARACTERISTICS: One of the following hematologic malignancies that has failed 1
or 2 prior front-line chemotherapy regimens and is ineligible for treatment of higher
potential efficacy: Histologically confirmed chronic lymphocytic leukemia (CLL)
Intermediate- or high-risk (RAI stage I-IV) disease Evidence of active disease required by
at least one of the following for intermediate-risk CLL: One of the following B symptoms:
Weight loss of 10% or more in previous 6 months Extreme fatigue Fever over 100 F without
evidence of infection Night sweats Massive (more than 6 cm below left costal margin) or
progressive splenomegaly Massive (more than 10 cm in longest diameter) or progressive
lymphadenopathy Progressive lymphocytosis with more than 50% increase over 2-month period
or anticipated doubling time of less than 12 months Progressive bone marrow failure as
manifested by development or worsening of anemia and/or thrombocytopenia Autoimmune anemia
and/or thrombocytopenia poorly responsive to corticosteroids Biopsy proven low-,
intermediate-, or high-grade non-Hodgkin's lymphoma Transformed lymphoma allowed
Measurable disease required Re-treatment on this study allowed if disease relapsed after a
complete remission

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy:
At least 12 weeks Hematopoietic: ANC at least 1,500/mm3 (at least 1,000/mm3 in CLL
patients with at least 30% marrow involvement) Platelets at least 100,000/mm3 (at least
50,000/mm3 in CLL patients with at least 30% marrow involvement) Hepatic: Bilirubin less
than 1.5 mg/dL Transaminases less than 2.5 times normal Renal: Creatinine no greater than
1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of
impaired cardiac status, e.g.: Severe coronary artery disease Cardiomyopathy Uncontrolled
congestive heart failure Arrhythmia Other: No known AIDS or HIV infection No second
malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer In situ
cervical cancer Not pregnant or nursing Effective contraception required of fertile
patients during and for 2 months after study

PRIOR CONCURRENT THERAPY: No concurrent therapy Biologic therapy: Not specified
Chemotherapy: See Disease Characteristics At least 4 weeks since chemotherapy (8 weeks
since nitrosoureas or mitomycin) and recovered Endocrine therapy: Not specified
Radiotherapy: At least 4 weeks since radiotherapy and recovered Surgery: Not specified
Other: No prior bone marrow transplant

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ayad M. Al-Katib, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000065273

NCT ID:

NCT00002908

Start Date:

December 1996

Completion Date:

November 2001

Related Keywords:

  • Leukemia
  • Lymphoma
  • refractory chronic lymphocytic leukemia
  • recurrent small lymphocytic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201