Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003968
First received: November 1, 1999
Last updated: February 7, 2013
Last verified: January 2004
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: bryostatin 1 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999) |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Enrollment: | 35 |
| Study Start Date: | June 1999 |
| Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Detailed Description:
OBJECTIVES:
I. Determine the objective response rate to bryostatin 1 in patients with advanced renal cell carcinoma.
II. Assess the toxicities of this treatment regimen in this patient population. III. Determine the time to disease progression in patients receiving this treatment regimen.
IV. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003968
Locations
| United States, New Jersey | |
| Hunterdon Regional Cancer Center | |
| Flemington, New Jersey, United States, 08822 | |
| Kimball Medical Center | |
| Lakewood, New Jersey, United States, 08701 | |
| South Jersey Hospital - Millville | |
| Millville, New Jersey, United States, 08332 | |
| Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County | |
| Mount Holly, New Jersey, United States, 08060 | |
| Riverview Medical Center | |
| Red Bank, New Jersey, United States, 07701 | |
| Community Medical Center | |
| Toms River, New Jersey, United States, 08755 | |
| St. Francis Medical Center | |
| Trenton, New Jersey, United States, 08629 | |
| United States, Pennsylvania | |
| Bon Secours-Holy Family Health System | |
| Altoona, Pennsylvania, United States, 16602 | |
| Delaware County Memorial Hospital | |
| Drexel Hill, Pennsylvania, United States, 19026 | |
| Pinnacle Health Hospitals | |
| Harrisburg, Pennsylvania, United States, 17105-8700 | |
| Conemaugh Memorial Hospital | |
| Johnstown, Pennsylvania, United States, 15905 | |
| Saint Mary Medical Center | |
| Langhorne, Pennsylvania, United States, 19047 | |
| North Penn Hospital | |
| Lansdale, Pennsylvania, United States, 19446 | |
| Paoli Memorial Hospital | |
| Paoli, Pennsylvania, United States, 19301-1792 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Pottstown Memorial Regional Cancer Center | |
| Pottstown, Pennsylvania, United States, 19464 | |
| Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19612-6052 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Naomi S. Balzer-Haas, MD | Fox Chase Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003968 History of Changes |
| Other Study ID Numbers: | NCI-2012-02303, FCCC-99012, NCI-T99-0002, CDR0000067169 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
stage IV renal cell cancer recurrent renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Kidney Diseases Urologic Diseases Bryostatin 1 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013