Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Kidney Cancer

Treatments: Drug: bryostatin 1

Study type: Interventional

Funder types: NIH

Identifiers

NCT00003968

FCCC-99012

CDR0000067169 (Registry Identifier)

NCI-T99-0002

NCI-2012-02303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

35 participants in 1 patient group

Arm I

Experimental group

Description:

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.

Treatment:

Drug: bryostatin 1