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A Phase lb Trial of the Combination of Bryostatin-1 and Low Dose Interleukin-2: Evaluation of the Functional and Molecular Status of Human Monocytes as Antigen Presenting Cells


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase lb Trial of the Combination of Bryostatin-1 and Low Dose Interleukin-2: Evaluation of the Functional and Molecular Status of Human Monocytes as Antigen Presenting Cells


OBJECTIVES:

- Determine the safety and side effects of bryostatin 1 and interleukin-2 in patients
with refractory solid tumors or lymphomas.

- Determine the maximum tolerated dose for interleukin-2 with bryostatin 1 in these
patients.

- Determine whether bryostatin 1 and interleukin-2 increase the expression of recognition
and costimulatory molecules on human monocytes and their ability to act as antigen
presenting cells.

- Assess any anti-tumor response in these patients treated with this regimen.

OUTLINE: This is a dose escalation study of interleukin-2.

Patients receive bryostatin 1 IV over 24 hours on days 1 and 8, and interleukin-2
subcutaneously on days 1-5 and days 8-12. Treatment continues every 28 days in the absence
of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of interleukin-2 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study in less than 2
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven solid tumor or lymphoma that is not curable by surgery,
radiotherapy, or standard chemotherapy, or for which no curative therapy exists

- Prostate cancer patients must have the following:

- Tumor progression following blockade of both testicular and adrenal androgens

- Serum testosterone in the castrate range (less than 20 ng/mL)

- At least 3 months since prior suramin therapy

- At least 4 weeks since prior flutamide or other antiandrogen medication and no
evidence of response to treatment

- Luprolide should continue if no prior orchiectomy

- No prior or concurrent brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0 or 1

Life expectancy:

- At least 3 months

Hematopoietic:

- WBC at least 3,500/mm^3 OR

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 8 g/dL

Hepatic:

- Hepatitis B surface antigen negative

- PT no greater than 14 seconds

- PTT no greater than 35 seconds

- Bilirubin no greater than 1.5 mg/dL unless due to Gilbert's disease

- SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2.5 times ULN

- Albumin at least 2.5 g/dL

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 50 mL/min

- Corrected calcium at least 8.0 mg/dL, but no greater than 10.7 mg/dL

Cardiovascular:

- No prior myocardial infarction, coronary artery disease (CAD), congestive heart
failure, second or third degree AV block, or cardiac arrhythmias requiring treatment

- No evidence of CAD on EKG

Pulmonary:

- FEV1-1 at least 70% predicted

- DLCO at least 60% predicted

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- At least 1 week since active infection requiring antibiotics

- No other medical or psychiatric condition that would preclude study

- No prior or concurrent seizure disorders controlled with medication

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior interleukin-2

- At least 4 weeks since other prior biologic therapy for solid tumors or lymphomas

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior bryostatin 1

- At least 4 weeks since other prior chemotherapy for solid tumors or lymphomas

Endocrine therapy:

- See Disease Characteristics

- At least 4 weeks since other prior endocrine therapy for solid tumors or lymphomas

- No absolute requirement for corticosteroids

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy for solid tumors or lymphomas

Surgery:

- See Disease Characteristics

- At least 4 weeks since prior surgery for solid tumors or lymphomas

Other:

- No absolute requirement for nonsteroidal anti-inflammatory drugs or H2 blockers

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Igor Espinoza-Delgado, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gerontology Research Center

Authority:

United States: Federal Government

Study ID:

CDR0000067198

NCT ID:

NCT00003993

Start Date:

September 1999

Completion Date:

Related Keywords:

  • Lymphoma
  • Small Intestine Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • small intestine lymphoma
  • unspecified adult solid tumor, protocol specific
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • primary central nervous system non-Hodgkin lymphoma
  • intraocular lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • stage IV mycosis fungoides/Sezary syndrome
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms

Name

Location

National Institute on Aging - BaltimoreBaltimore, Maryland  21224-6825