NCT00006022

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining bryostatin 1 with interleukin-2 may kill more tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of interleukin-2 plus bryostatin 1 in treating patients who have melanoma or kidney cancer that cannot be removed during surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2000

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2000

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

3.1 years

First QC Date

July 5, 2000

Last Update Submit

December 10, 2015

Conditions

Kidney CancerMelanoma (Skin)

Keywords

stage III renal cell cancerstage IV renal cell cancerrecurrent renal cell cancerstage III melanomastage IV melanomarecurrent melanoma

Interventions

aldesleukinBIOLOGICAL
bryostatin 1DRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed cutaneous or mucosal melanoma or renal cell carcinoma * Unresectable disease * No known uncontrolled CNS metastases * CNS metastases allowed only if recently irradiated or known to be controlled PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Hemoglobin at least 8 g/dL * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Absolute lymphocyte count at least 1,000/mm\^3 Hepatic: * Total bilirubin no greater than 1.5 mg/dL OR * Conjugated bilirubin no greater than 0.3 mg/dL * AST no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 2 mg/dL Cardiovascular: * No myocardial infarction within the past 6 months * No uncontrolled hypertension, angina, or congestive heart failure Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after study * No known intolerance to acetaminophen * No primary or secondary immunodeficiency * No other condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * At least 1 month since prior topical, systemic, or inhaled corticosteroids * No concurrent topical, systemic, or inhaled corticosteroids Radiotherapy: * See Disease Characteristics Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (2)

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Massey Cancer Center

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsMelanomaCarcinoma, Renal Cell

Interventions

aldesleukinbryostatin 1

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and Epithelial

Study Officials

  • John D. Roberts, MD

    Massey Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

September 1, 2000

Primary Completion

October 1, 2003

Study Completion

January 1, 2004

Last Updated

December 14, 2015

Record last verified: 2015-12

Locations

US(2)