Completed

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

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What is being tested

aldesleukin

+ bryostatin 1

BiologicalDrug
Who is being recruted

Lymphadenopathy+41

+ Chronic Disease

+ DNA Virus Infections

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 1999
See protocol details

Summary

Principal SponsorNational Institute on Aging (NIA)
Last updated: April 29, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00003993
Principal SponsorNational Institute on Aging (NIA)
Last updated: April 29, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

LymphadenopathyChronic DiseaseDNA Virus InfectionsEye NeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SitePathologic ProcessesPathological Conditions, Signs and SymptomsTumor Virus InfectionsVirus DiseasesLeukemia, B-CellLymphoma, B-CellLymphoma, T-CellEpstein-Barr Virus InfectionsDisease AttributesBurkitt LymphomaHodgkin DiseaseImmunoblastic LymphadenopathyLymphomaLymphoma, FollicularLymphoma, Non-HodgkinMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, T-Cell, CutaneousLymphoma, Large-Cell, AnaplasticLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-CellPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaIntraocular Lymphoma

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institute on Aging - Baltimore

Baltimore, United StatesOpen National Institute on Aging - Baltimore in Google Maps
CompletedOne Study Center