Bryostatin 1 Plus Vincristine in Treating Patients With Progressive or Relapsed Non-Hodgkin's Lymphoma After Bone Marrow or Stem Cell Transplantation
A Phase II Study of Bryostatin 1 and Vincristine in Patients With Low or Intermediate Grade Non-Hodgkin's Lymphoma Progressing or Relapsing After a Prior Autologous Bone Marrow or Stem Cell Transplant
3 other identifiers
interventional
28
1 country
1
Brief Summary
Phase II trial to study the effectiveness of combining bryostatin 1 with vincristine in treating patients who have progressive or relapsed non-Hodgkin's lymphoma after autologous bone marrow transplantation or autologous stem cell transplantation. Drugs used in chemotherapy such as vincristine use different ways to stop cancer cells from dividing so they stop growing or die. Bryostatin 1 may help vincristine kill more cancer cells by making the cells more sensitive to the drug
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 7, 2003
CompletedFirst Posted
Study publicly available on registry
April 9, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedJanuary 10, 2013
January 1, 2013
4.8 years
April 7, 2003
January 9, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Response in terms of sustained increase in apoptotic fractions
Up to 5 years
Secondary Outcomes (2)
Complete response duration
Up to 5 years
Incidence of greater than or equal to grade 3 myelotoxicity
Up to 5 years
Study Arms (1)
Treatment (bryostatin 1, vincristine sulfate)
EXPERIMENTALPatients receive bryostatin 1 IV over 24 hours on days 1 and 15 and vincristine IV on days 2 and 16. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients without disease progression after 6 courses may continue therapy with bryostatin 1 IV over 24 hours on days 1 and 22 and vincristine IV on days 2 and 23. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Patients must have biopsy proven relapsed or progressive low or intermediate grade non-Hodgkin's lymphoma (by REAL classification); after prior autologous bone marrow transplantation or peripheral blood stem cell rescue
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan
- Patients must have received a prior autologous bone marrow or peripheral blood stem cell rescue to be eligible for this trial (there is no specified time interval from transplant prior to enrollment on study; at least 4 weeks must have elapsed since prior large-field radiation therapy; patients must have been off previous anti-cancer therapy for at least 4 weeks and recovered from all treatment related toxicity; prior vincristine therapy is allowed
- Life expectancy of greater than 8-10 weeks
- ECOG performance status 0-2
- Absolute neutrophil count \>= 1,250/uL
- Platelets \>= 50,000/uL
- Hemoglobin \>= 8.5 g /dl
- Total bilirubin =\< 2.0 mg/dl
- AST(SGOT)/ALT(SGPT) =\< 3 X normal
- Creatinine =\< 2.0 mg/dl
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if:
- Patients requiring concomitant anticancer therapy are excluded
- Patients with known brain metastases or leptomeningeal involvement should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- Patients who have had a prior allogeneic transplant are not eligible
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant and lactating women are excluded from this study
- HIV infection
- Patients with clinically apparent neuropathy (\>= grade 2)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brenda Cooper
Case Western Reserve University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2003
First Posted
April 9, 2003
Study Start
March 1, 2003
Primary Completion
December 1, 2007
Last Updated
January 10, 2013
Record last verified: 2013-01