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Phase II Clinical Evaluation of Bryostatin 1 in Patients With Hodgkin's Disease


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

Phase II Clinical Evaluation of Bryostatin 1 in Patients With Hodgkin's Disease


OBJECTIVES: I. Determine the response rate in patients with recurrent or refractory
Hodgkin's disease treated with bryostatin 1. II. Determine qualitative and quantitative
toxicities of bryostatin 1 in these patients. III. Determine duration of response and
survival in these patients.

OUTLINE: Patients receive bryostatin 1 by continuous IV infusion over 72 hours. Courses
repeat every 14 days in the absence of disease progression or unacceptable toxicity for at
least 4 courses. Patients who achieve complete response (CR) are treated with 4 additional
courses beyond CR.

PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of recurrent or refractory Hodgkin's disease Measurable
disease Must have failed the following regimens: Mechlorethamine, vincristine,
procarbazine, and prednisone (MOPP) AND Doxorubicin, bleomycin, vinblastine, and
dacarbazine (ABVD) May have undergone either bone marrow or peripheral blood stem cell
transplant Must not be eligible for standard treatment (high intensity therapy with
peripheral blood stem cell or bone marrow transplant) or higher priority protocol

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy:
At least 12 weeks Hematopoietic: Absolute neutrophil count (ANC) at least 1,000/mm3 (at
least 500/mm3 if extensive bone marrow involvement) Platelets at least 75,000/mm3 (at
least 50,000/mm3 if extensive bone marrow involvement) Hepatic: Bilirubin less than 1.5
mg/dL ALT and AST less 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: Not pregnant or nursing
Fertile patients must use effective contraception during and for 2 months after study

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David S. Eilender, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067128

NCT ID:

NCT00003936

Start Date:

June 1999

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201