Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00003968

Collaborator

(none)

Enrollment

Locations

Arm

2.1

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Drug: bryostatin 1	Phase 2

Detailed Description

OBJECTIVES:

Determine the objective response rate to bryostatin 1 in patients with advanced renal cell carcinoma.
Assess the toxicities of this treatment regimen in this patient population. III. Determine the time to disease progression in patients receiving this treatment regimen.
Determine the overall survival of this patient population treated with this regimen.

OUTLINE:

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.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999)

Study Start Date :

Jun 1, 1999

Actual Primary Completion Date :

Dec 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I 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

Arm

Intervention/Treatment

Experimental: Arm I

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hunterdon Regional Cancer Center	Flemington	New Jersey	United States	08822
2	Kimball Medical Center	Lakewood	New Jersey	United States	08701
3	South Jersey Hospital - Millville	Millville	New Jersey	United States	08332
4	Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County	Mount Holly	New Jersey	United States	08060
5	Riverview Medical Center	Red Bank	New Jersey	United States	07701
6	Community Medical Center	Toms River	New Jersey	United States	08755
7	St. Francis Medical Center	Trenton	New Jersey	United States	08629
8	Bon Secours-Holy Family Health System	Altoona	Pennsylvania	United States	16602
9	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania	United States	19026
10	Pinnacle Health Hospitals	Harrisburg	Pennsylvania	United States	17105-8700
11	Conemaugh Memorial Hospital	Johnstown	Pennsylvania	United States	15905
12	Saint Mary Medical Center	Langhorne	Pennsylvania	United States	19047
13	North Penn Hospital	Lansdale	Pennsylvania	United States	19446
14	Paoli Memorial Hospital	Paoli	Pennsylvania	United States	19301-1792
15	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
16	Pottstown Memorial Regional Cancer Center	Pottstown	Pennsylvania	United States	19464
17	Reading Hospital and Medical Center	Reading	Pennsylvania	United States	19612-6052