Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

Breast Cancer Clinical Trial

Official title:

A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002475
• Other study ID #: SVMC-ONC-222
• Secondary ID: CDR0000076913NCI
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 9, 2013
• Start date: April 1991
• Est. completion date: June 2009

Study information

• Verified date: November 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Kidney Cancer
• Lung Cancer
• Lung Neoplasms
• Malignant Mesothelioma
• Mesothelioma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• allogeneic tumor cell vaccine

• autologous tumor cell vaccine

• recombinant interferon alfa

• recombinant interferon gamma

• sargramostim

Drug:
• cyclophosphamide

Locations

Country	Name	City	State
United States	St. Vincent Medical Center - Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
St. Vincent Medical Center - Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response (patients with evaluable disease)			No
Primary	Duration of response (patients with evaluable disease)			No
Primary	Survival (patients with evaluable disease)			No
Primary	Time to recurrence (patients without evaluable disease)			No
Primary	Survival (patients without evaluable disease)			No