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A Phase II Trial Of Bryostatin-1 In Combination With Rituximab In Rituximab-Refractory Indolent B-cell Non Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma

Thank you

Trial Information

A Phase II Trial Of Bryostatin-1 In Combination With Rituximab In Rituximab-Refractory Indolent B-cell Non Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia


OBJECTIVES:

Primary

- Determine the feasibility and safety of bryostatin 1 and rituximab in patients with
rituximab-refractory indolent B-cell non-Hodgkin's lymphoma or chronic lymphocytic
leukemia (CLL).

- Determine the antitumor response in patients treated with this regimen.

Secondary

- Determine the effects of this regimen on the functional and molecular status of
effector cells (i.e., NK cells, monocytes, and dendritic cells) in these patients.

- Determine the expression of CD20 and complement-inhibitory molecules on tumor cells
before and after treatment with this regimen in these patients.

- Determine the effects of this regimen on the global gene expression pattern in CLL
cells of these patients.

OUTLINE: This is a multicenter study.

Patients receive bryostatin 1 IV continuously over 24 hours on days -6, 2, and 9 of course 1
and on days 2 and 9 of courses 2-6. Patients also receive rituximab IV over 4 hours on days
1, 8, 15, and 22 of courses 1 and 4. Treatment repeats every 28 days for 6 courses in the
absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 18-48 patients (9-24 with non-Hodgkin's lymphoma and 9-24
with chronic lymphocytic leukemia) will be accrued for this study within 12-30 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- One of the following histologically or cytologically confirmed diseases:

- Indolent B-cell non-Hodgkin's lymphoma (NHL)

- Stage II-IV disease

- Chronic lymphocytic leukemia (CLL) meeting 1 of the following risk criteria:

- Intermediate-risk with progressive disease

- High-risk, modified Rai stage disease

- CD20-positive by flow cytometry or immunohistochemistry

- Measurable disease

- Rituximab-refractory disease, defined as failure to achieve a response to the last
course of prior treatment with rituximab alone or in combination with other
therapeutic modalities

- No known neoplastic leptomeningeal involvement and/or brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy

- More than 3 months

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 50,000/mm^3

- WBC ≥ 3,000/mm^3

Hepatic

- AST and ALT ≤ 2.5 times upper limit of normal

- Bilirubin normal (unless due to Gilbert's disease or organ involvement by NHL or CLL)

Renal

- Creatinine normal OR

- Creatinine clearance ≥ 60 mL/min

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No history of anaphylaxis or immunoglobulin (Ig) E-mediated hypersensitivity to
murine protein

- Prior infusion reactions to rituximab without an IgE component allowed

- No active or ongoing infection

- No psychiatric illness or social situation that would preclude study compliance

- No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- See Radiotherapy

- At least 12 weeks since prior rituximab

- More than 4 weeks since prior immunotherapy and recovered

Chemotherapy

- No more than 3 prior chemotherapy regimens

- More than 4 weeks since prior chemotherapy and recovered

Endocrine therapy

- No concurrent glucocorticoids

Radiotherapy

- At least 12 weeks since prior radioimmunotherapy

- More than 4 weeks since prior radiotherapy and recovered

Surgery

- Not specified

Other

- At least 4 weeks since prior therapy for the malignancy

- No other concurrent anticancer therapy

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasability and safety

Safety Issue:

Yes

Principal Investigator

Igor Espinoza-Delgado, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gerontology Research Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000377250

NCT ID:

NCT00087425

Start Date:

July 2004

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • recurrent grade 1 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • contiguous stage II marginal zone lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • stage III marginal zone lymphoma
  • stage IV marginal zone lymphoma
  • refractory chronic lymphocytic leukemia
  • Waldenström macroglobulinemia
  • contiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

NIH - Warren Grant Magnuson Clinical CenterBethesda, Maryland  20892-1182