Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

June 11, 2009

Start Date ^ICMJE

April 1991

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical response (patients with evaluable disease) [ Designated as safety issue: No ]
Duration of response (patients with evaluable disease) [ Designated as safety issue: No ]
Survival (patients with evaluable disease) [ Designated as safety issue: No ]
Time to recurrence (patients without evaluable disease) [ Designated as safety issue: No ]
Survival (patients without evaluable disease) [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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)

Change History

Complete list of historical versions of study NCT00002475 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

Official Title ^ICMJE

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Biological: allogeneic tumor cell vaccine
Biological: autologous tumor cell vaccine
Biological: recombinant interferon alfa
Biological: recombinant interferon gamma
Biological: sargramostim
Drug: cyclophosphamide

Study Arms / Comparison Groups

Publications *

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. No abstract available.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00002475

Responsible Party

Charles L. Wiseman

Study ID Numbers ^ICMJE

CDR0000076913, SVMC-ONC-222, NCI-V91-0075

Study Sponsor ^ICMJE

St. Vincent Medical Center - Los Angeles

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Charles L. Wiseman, MD, FACP

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP