Clinical Trial: Bryostatin 1 in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

This study has been completed.

Sponsors and Collaborators: National Cancer Institute (NCI)
Barbara Ann Karmanos Cancer Institute
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of bryostatin 1 in treating patients who have relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Condition Treatment or Intervention Phase
recurrent diffuse small lymphocytic/marginal zone lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade III follicular large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent mantle cell lymphoma
refractory chronic lymphocytic leukemia
recurrent small lymphocytic lymphoma
recurrent adult diffuse large cell lymphoma
recurrent grade I follicular small cleaved cell lymphoma
recurrent grade II follicular mixed cell lymphoma
 Drug: bryostatin 1
 Drug: bryostatin 1/vincristine
 Drug: vincristine
Phase II

MedlinePlus related topics:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Bryostatin 1 in Relapsed non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia with Addition of Vincristine for Disease Progression

Further Study Details: 

Study start: December 1996

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.

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Location Information


Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States

Study chairs or principal investigators

Ayad M. Al-Katib,  Study Chair,  Barbara Ann Karmanos Cancer Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065273; WSU-C-1256; NCI-T95-0058D; WSU-D-1256
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002908
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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