Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information

Alternate Title

Gemcitabine, Carboplatin, and Dexamethasone With or Without Rituximab in Treating Patients With Relapsed or Primary Refractory Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over NCI, Pharmaceutical / Industry UW-LYM.03.01 LILLY-B9E-US-X348, PSOC-2003

Objectives

1. Determine the feasibility and safety of gemcitabine, carboplatin, and dexamethasone with or without rituximab, in terms of response rate, in patients with relapsed or primary refractory lymphoid malignancy.
2. Determine the efficacy of these regimens in these patients.
3. Determine the impact of these regimens on stem cell reserve in these patients.
4. Determine the remission duration in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Diagnosis of relapsed or primary refractory lymphoid malignancy, including the following types:
  • B-cell lymphoma
  • T-cell lymphoma
  • Hodgkin’s lymphoma



• No disease refractory (i.e., not responded or progressed within 6 months) to a carboplatin- or cisplatin-based regimen or a gemcitabine-based regimen



• Bidimensionally measurable disease
  • At least 1 cm by CT scan, MRI, medical photograph (skin or oral lesion), plain x-ray, or other conventional techniques OR at least 2 cm by palpation



• Bone marrow aspirate and biopsy within the past 28 days
  • No prior anticancer therapy during the interval between bone marrow aspirate and biopsy and study entry



• No active CNS lymphoma

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age

• 18 and over

Performance status

• SWOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin less than 2 times upper limit of normal (ULN)

Renal

• Creatinine less than 1.5 times ULN
• Creatine clearance greater than 50 mL/min

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 6 months after study participation
• HIV negative
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No other medical condition that would preclude study treatment

Projected Accrual

Approximately 51 patients will be accrued for this study within 2-3 years.

Outline

This is a pilot study. Patients are stratified according to CD20 expression (negative vs positive).

• Stratum I (CD20 negative): Patients receive carboplatin IV over 30 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; and oral dexamethasone on days 1-4.



• Stratum II (CD20 positive): Patients receive carboplatin, gemcitabine, and dexamethasone as in stratum I and rituximab IV on day 8.

In both strata, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 5 years.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Trial Contact Information

Trial Lead Organizations

University of Washington School of Medicine

Ajay Gopal, MD, Protocol chair		Ph: 206-288-2037
John Pagel, MD, PhD, Protocol co-chair		Ph: 206-667-1868

U.S.A.
Washington
	Seattle
	Seattle Cancer Care Alliance
		Ajay Gopal, MD	Ph:  206-288-2037

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