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Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003993
First received: November 1, 1999
Last updated: March 13, 2010
Last verified: May 2006
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining chemotherapy and interleukin-2 may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-2 when given together with bryostatin 1 in treating patients with refractory solid tumors or lymphoma.


Condition Intervention Phase
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Biological: aldesleukin
Drug: bryostatin 1
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 24
Study Start Date: September 1999
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003993

Locations
United States, Maryland
National Institute on Aging - Baltimore
Baltimore, Maryland, United States, 21224-6825
Sponsors and Collaborators
Investigators
Study Chair: Igor Espinoza-Delgado, MD Gerontology Research Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003993     History of Changes
Other Study ID Numbers: CDR0000067198, NCI-T99-0015, LSUMC-9901
Study First Received: November 1, 1999
Last Updated: March 13, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bryostatin 1
Interleukin-2
Adjuvants, Immunologic
Analgesics
Analgesics, Non-Narcotic
Antineoplastic Agents
Central Nervous System Agents
Immunologic Factors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014