Bryostatin 1 in Treating Patients With Recurrent or Refractory Hodgkin's Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00003936
First received: November 1, 1999
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have recurrent or refractory Hodgkin's disease.


Condition Intervention Phase
Lymphoma
Drug: bryostatin 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Clinical Evaluation of Bryostatin 1 in Patients With Hodgkin's Disease

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Study Start Date: June 1999
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00003936

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: David S. Eilender, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00003936     History of Changes
Other Study ID Numbers: CDR0000067128, P30CA022453, WSU-C-1902, NCI-T97-0120
Study First Received: November 1, 1999
Last Updated: April 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
recurrent adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bryostatin 1
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014