Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

NCT ID: NCT00002475

Last Updated: 2013-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1991-04-30
• Study Completion Date: 2009-06-30

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from a patient's tumor tissue may make the body build an immune response to kill tumor cells. Chemotherapy combined with vaccine therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide with tumor cell vaccine in treating patients who have metastatic cancer or cancer at high risk of recurrence.

Detailed Description

OBJECTIVES:

• 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.

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.

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

Conditions

Breast Cancer; Colorectal Cancer; Kidney Cancer; Lung Cancer; Malignant Mesothelioma; Pancreatic Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

allogeneic tumor cell vaccine

Intervention Type: BIOLOGICAL

autologous tumor cell vaccine

Intervention Type: BIOLOGICAL

recombinant interferon alfa

Intervention Type: BIOLOGICAL

recombinant interferon gamma

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Vincent Medical Center - Los Angeles

OTHER

Sponsor Role: lead

Principal Investigators

Charles L. Wiseman, MD, FACP

Role: STUDY_CHAIR

Locations

St. Vincent Medical Center - Los Angeles

Los Angeles, California, United States

Countries

United States

References

Wiseman C, Presant C, Rao R, Smith J. Clinical responses to intralymphatic whole-cell melanoma vaccine augmented by in vitro incubation with alpha-interferon. Ann N Y Acad Sci. 1993 Aug 12;690:388-91. doi: 10.1111/j.1749-6632.1993.tb44040.x. No abstract available.

Reference Type: RESULT

PMID: 8368765 (View on PubMed)

Other Identifiers

CDR0000076913

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-V91-0075

Identifier Type: -

Identifier Source: secondary_id

SVMC-ONC-222

Identifier Type: -

Identifier Source: org_study_id