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

Alternate Title

Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	Other	SVMC-ONC-222 NCI-V91-0075, NCT00002475

Objectives

1. Determine the safety and clinical effects of autologous or allogeneic active-specific intralymphatic immunotherapy with a vaccine containing interferon alfa or interferon gamma-treated tumor cells followed by sargramostim (GM-CSF) in patients with advanced cancer.

Entry Criteria

Disease Characteristics:

• Histologically confirmed cancer not amenable to cure or long-term control by surgery, radiotherapy, chemotherapy, or hormonal manipulations, including the following tumor types:
  • Colon cancer
  • Lung cancer
  • Renal cancer
  • Breast cancer
  • Pancreatic cancer



• Metastatic disease or subclinical disease at high risk of recurrence



• No brain metastases unresponsive to irradiation or surgery



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy

Endocrine therapy:

• See Disease Characteristics
• At least 4 weeks since prior hormonal therapy
• No concurrent chronic steroid therapy

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy

Surgery:

• See Disease Characteristics

Patient Characteristics:

Age:

• 18 and over

Sex:

• Not specified

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2

  OR

• Karnofsky 70-100%

Life expectancy:

• At least 3 months

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• No prior or concurrent significant cardiovascular disease

Pulmonary:

• No prior or concurrent pulmonary disease

Other:

• No prior or concurrent autoimmune disease
• No other prior or concurrent major medical illness
• HIV negative
• No clinical evidence of AIDS
• Not pregnant

Expected Enrollment

A total of 20-40 patients will be accrued for this study within 18-24 months.

Outcomes

Clinical response (patients with evaluable disease)
Duration of response (patients with evaluable disease)
Survival (patients with evaluable disease)
Time to recurrence (patients without evaluable disease)
Survival (patients without evaluable disease)

Outline

This is a pilot study. Patients are stratified by tumor type.

Tumor tissue is removed from the patient and incubated with interferon alfa or interferon gamma for 72-96 hours. (If autologous tumor cells are not available, an allogeneic vaccine is prepared.) Harvested activated cells are irradiated immediately prior to use.

Patients receive cyclophosphamide IV. 48-72 hours after cyclophosphamide administration, patients receive tumor cell vaccine intradermally. Patients also receive sargramostim (GM-CSF) subcutaneously prior to vaccine administration and once daily for the next 8 days. Treatment repeats every 2 weeks for 3 courses in the absence of unacceptable toxicity. Patients with responding or stable disease after completion of course 3 may receive additional courses.

Patients are followed for survival.

Wiseman C, Presant C, Rao R, et al.: Clinical responses to intralymphatic whole-cell melanoma vaccine augmented by in vitro incubation with alpha-interferon. Ann N Y Acad Sci 690: 388-91, 1993.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

St. Vincent Medical Center - Los Angeles

Charles Wiseman, MD, FACP, Protocol chair		Ph: 213-483-8464

Registry Information
Official Title		A Trial of Active Intralymphatic Immunotherapy with Interferon-Treated Cells and Cyclophosphamide
Trial Start Date		1991-04-01
Trial Completion Date		2007-12-18
Registered in ClinicalTrials.gov		NCT00002475
Date Submitted to PDQ		1991-04-01
Information Last Verified		2008-11-24

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