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


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Colorectal Cancer, Kidney Cancer, Lung Cancer, Malignant Mesothelioma, Pancreatic Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Clinical response (patients with evaluable disease)

Safety Issue:

No

Principal Investigator

Charles L. Wiseman, MD, FACP

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

SVMC-ONC-222

NCT ID:

NCT00002475

Start Date:

April 1991

Completion Date:

June 2009

Related Keywords:

  • Breast Cancer
  • Colorectal Cancer
  • Kidney Cancer
  • Lung Cancer
  • Malignant Mesothelioma
  • Pancreatic Cancer
  • stage III colon cancer
  • stage IV colon cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • recurrent non-small cell lung cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • recurrent colon cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IIIC breast cancer
  • stage IV non-small cell lung cancer
  • pulmonary carcinoid tumor
  • recurrent malignant mesothelioma
  • stage IV pancreatic cancer
  • Breast Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Mesothelioma
  • Pancreatic Neoplasms

Name

Location

St. Vincent Medical Center - Los AngelesLos Angeles, California  90057