NCT00003968

Brief Summary

Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have metastatic kidney cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

17 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

Study Start

First participant enrolled

June 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 3, 2004

Completed
Last Updated

February 8, 2013

Status Verified

January 1, 2004

Enrollment Period

4.5 years

First QC Date

November 1, 1999

Last Update Submit

February 7, 2013

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancerrecurrent renal cell cancer

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion.

Drug: bryostatin 1

Interventions

bryostatin 1DRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic renal cell carcinoma * Bidimensionally measurable disease * Clear evidence of progression if only site of measurable disease is within previous radiation port * Previously irradiated brain metastases allowed, if not life threatening, symptoms controlled for 3 months, and not requiring corticosteroids PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0-1 * Life expectancy: Greater than 3 months * WBC at least 3,000/mm3 * Platelet count at least 100,00/mm3 * Bilirubin no greater than 1.5 mg/dL * Creatinine no greater than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for 1 month before, during, and for 3 months after study * No active bacterial or viral infection * No serious underlying medical condition that would interfere with compliance * No other malignancy within the past 5 years except basal cell carcinoma of the skin * No dementia or altered mental status that would prevent informed consent PRIOR CONCURRENT THERAPY: * No more than 1 prior therapy with biologic response modifiers * No prior chemotherapy for advanced disease * No other concurrent chemotherapy * No concurrent steriods (except topical use) * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy * At least 4 weeks since major surgery (including nephrectomy) * No other concurrent experimental agents

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

Sponsors & Collaborators

Study Sites (17)

Hunterdon Regional Cancer Center

Flemington, New Jersey, 08822, United States

Location

Kimball Medical Center

Lakewood, New Jersey, 08701, United States

Location

South Jersey Hospital - Millville

Millville, New Jersey, 08332, United States

Location

Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County

Mount Holly, New Jersey, 08060, United States

Location

Riverview Medical Center

Red Bank, New Jersey, 07701, United States

Location

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

St. Francis Medical Center

Trenton, New Jersey, 08629, United States

Location

Bon Secours-Holy Family Health System

Altoona, Pennsylvania, 16602, United States

Location

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

Pinnacle Health Hospitals

Harrisburg, Pennsylvania, 17105-8700, United States

Location

Conemaugh Memorial Hospital

Johnstown, Pennsylvania, 15905, United States

Location

Saint Mary Medical Center

Langhorne, Pennsylvania, 19047, United States

Location

North Penn Hospital

Lansdale, Pennsylvania, 19446, United States

Location

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301-1792, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Pottstown Memorial Regional Cancer Center

Pottstown, Pennsylvania, 19464, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

bryostatin 1

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Naomi S. Balzer-Haas, MD

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 3, 2004

Study Start

June 1, 1999

Primary Completion

December 1, 2003

Last Updated

February 8, 2013

Record last verified: 2004-01

Locations

US(17)