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


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Naomi S. Balzer-Haas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02303

NCT ID:

NCT00003968

Start Date:

June 1999

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
South Jersey Hospital - MillvilleMillville, New Jersey  08332
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington CountyMount Holly, New Jersey  08060
Community Medical CenterToms River, New Jersey  08755
St. Francis Medical CenterTrenton, New Jersey  08629
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Hunterdon Regional Cancer CenterFlemington, New Jersey  08822
Riverview Medical CenterRed Bank, New Jersey  07701
Kimball Medical CenterLakewood, New Jersey  08701
North Penn HospitalLansdale, Pennsylvania  19446-1200
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Pinnacle Health HospitalsHarrisburg, Pennsylvania  17105-8700
Conemaugh Memorial HospitalJohnstown, Pennsylvania  15905
Pottstown Memorial Regional Cancer CenterPottstown, Pennsylvania  19464
Bon Secours-Holy Family Health SystemAltoona, Pennsylvania  16602
Saint Mary Medical CenterLanghorne, Pennsylvania  19047