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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma

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Trial Information

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


PRIMARY OBJECTIVES:

I. To evaluate response rate when bryostatin 1 is given in combination with vincristine in
patients with low and intermediate grade non-Hodgkin's lymphoma who have progressed or
relapsed following an autologous bone marrow or stem cell transplant.

II. To determine if blunting of apoptotic response (with two or more consecutive apoptotic
fractions) following treatment using annexin V staining of peripheral blood CD5+ and CD19+
lymphocytes by flow cytometry is predictive of outcome (i.e. lack of clinical response).

III. To prospectively evaluate the incidence of > grade 3 myelotoxicity with this regimen.

OUTLINE: This is a multicenter study.

Patients 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.

Patients are followed every 3 months for 2 years, every 6 months for 2-5 years, and then
annually thereafter.


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response in terms of sustained increase in apoptotic fractions

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Brenda Cooper

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Western Reserve University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03116

NCT ID:

NCT00058305

Start Date:

March 2003

Completion Date:

Related Keywords:

  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Nodal Marginal Zone B-cell Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell

Name

Location

Case Western Reserve UniversityCleveland, Ohio  44106