Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	WSU-Z-2021 NCI-T99-0014, NCT00004144, T99-0014

Objectives

1. Determine the maximum tolerated dose of gemcitabine when given concurrently with bryostatin 1 to patients with advanced refractory cancer.
2. Access the pattern of toxicity of this drug regimen in this patient population.
3. Determine the objective response rate, duration of response, and overall survival in patients treated with this drug regimen.
4. Determine the influence of bryostatin 1 on the pharmacokinetics of gemcitabine.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically proven advanced cancer (except hematological cancers) for which there is no standard therapy or have failed standard therapies



• Measurable or evaluable disease



• Clinically controlled brain metastases allowed

Prior/Concurrent Therapy:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• At least 3 weeks since systemic cytotoxic chemotherapy (including gemcitabine) and recovered
• No other concurrent chemotherapy

Endocrine therapy:

• Prior hormonal therapy allowed
• No concurrent hormonal therapy (excluding contraceptives, appetite stimulants, or replacement steroids)

Radiotherapy:

• At least 3 weeks since radiotherapy to large areas of active bone marrow and recovered
• No concurrent radiotherapy

Surgery:

• Recovered from prior major surgery

Other:

• No concurrent antiviral nucleosides
• At least 1 month since prior investigational agents
• No other concurrent experimental medications

Patient Characteristics:

Age:

• 18 and over

Performance status:

• SWOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Hemoglobin at least 8.0 g/dL
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN) (elevated bilirubin due to Gilbert's syndrome allowed if direct bilirubin normal)
• AST less than 2.5 times ULN

Renal:

• Creatinine normal

Cardiovascular:

• No active cardiac disease

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No concurrent bacterial infection requiring antibiotics
• No serious concurrent medical condition

Expected Enrollment

Approximately 2-3 patients per month will be accrued for this study.

Outline

This is a dose escalation study.

Patients receive gemcitabine IV over 30 minutes, immediately followed by bryostatin 1 IV over 24 hours, weekly for 3 weeks (days 1, 8, and 15). Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of gemcitabine and bryostatin 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxic effects.

El-Rayes BF, Gadgeel S, Shields AF, et al.: Phase I study of bryostatin 1 and gemcitabine. Clin Cancer Res 12 (23): 7059-62, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Barbara Ann Karmanos Cancer Institute

Philip Philip, MD, PhD, FRCP, Protocol chair		Ph: 313-576-8728; 800-527-6266 Email: philipp@karmanos.org

Registry Information
Official Title		Phase I Study of Bryostatin 1 and Gemcitabine (Gemzar)
Trial Start Date		2000-05-16
Registered in ClinicalTrials.gov		NCT00004144
Date Submitted to PDQ		1999-10-07
Information Last Verified		2004-05-18
NCI Grant/Contract Number		CA22453

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