Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

Brief Title

Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

Official Title

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 2

Study Type

Interventional

Primary Outcome

Clinical response (patients with evaluable disease)

Condition

Breast Cancer

Intervention

allogeneic tumor cell vaccine

Publications

* 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

Biological

Estimated Enrollment

Start Date

April 1991

Completion Date

June 2009

Primary Completion Date

December 2007

Eligibility 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Charles L. Wiseman, MD, FACP, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00002475

Organization ID

SVMC-ONC-222

Secondary IDs

CDR0000076913

Study Sponsor

St. Vincent Medical Center - Los Angeles

Study Sponsor

Charles L. Wiseman, MD, FACP, Study Chair,

Verification Date

November 2008