NCT00003993

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Last Updated

April 29, 2015

Status Verified

May 1, 2006

Enrollment Period

8.8 years

First QC Date

November 1, 1999

Last Update Submit

April 28, 2015

Conditions

LymphomaSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomasmall intestine lymphomaunspecified adult solid tumor, protocol specificstage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomaprimary central nervous system non-Hodgkin lymphomaintraocular lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomastage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromerecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

aldesleukinBIOLOGICAL
bryostatin 1DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute on Aging - Baltimore

Baltimore, Maryland, 21224-6825, United States

Location

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaIntraocular LymphomaLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

aldesleukinbryostatin 1

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye NeoplasmsNeoplasms by SiteLymphadenopathyLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Igor Espinoza-Delgado, MD

    Gerontology Research Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

September 1, 1999

Primary Completion

July 1, 2008

Last Updated

April 29, 2015

Record last verified: 2006-05

Locations

US(1)