Clinical trial NCT00002455: Immunotherapy After Surgery in Treating Patients With Breast Cancer, Colon Cancer, or Melanoma
Official title: Immunotherapy of Colon Cancer With Autologous Perchloric Soluble Tumors Extracts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Colorectal Cancer
Melanoma (Skin)
Keywords: stage I colon cancer
stage II colon cancer
stage III colon cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
recurrent breast cancer
recurrent colon cancer
stage I melanoma
stage II melanoma
stage III melanoma
recurrent melanoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Immunotherapy uses different ways to stimulate the immune system and stop cancer cells from growing. Immunotherapy biological extracts may be useful as adjuvant therapy in treating patients who have had surgery for breast cancer, colon cancer, or melanoma.

PURPOSE: Phase III trial to study the effectiveness of Corynebacterium granulosum extract as maintenance immunotherapy following surgery in treating patients with breast cancer, colon cancer, or melanoma.

Detailed description: OBJECTIVES:

* Determine the survival of patients with colon cancer, breast cancer, or melanoma with minimal residual disease after surgical resection treated with maintenance immunotherapy using Corynebacterium granulosum P40.
* Determine leucocyte adherence inhibition, an indication of metastases, over time in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified by center and are matched with case-controls by disease type and stage.

Beginning 2 weeks after surgical resection, patients receive Corynebacterium granulosum P40 subcutaneously weekly for 6 weeks, followed by rest for 3 months. Treatment continues for life.

Patients are followed for survival.

PROJECTED ACCRUAL: Not specified

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of colon cancer, breast cancer, or melanoma with minimal residual disease (at least 90% of tumor mass resected) after surgical resection
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 20 to 80

Sex:

* Not specified

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* See Disease Characteristics

Primary outcomes:
measure: Recurrence
measure: Response to study parameters
measure: Survival rate
Secondary outcomes:
Other outcomes:
Locations:
city: Gonnet
country: Argentina
facility: Centro Oncologico de Excelencia
state: Buenos Aires
Study officials:
affiliation: Centro Oncologico de Excelencia
name: Hugo Omar De Carli, MD
role: STUDY_CHAIR
References:
citation: De Carli HO: Immunostimulation and follow-up in long term subclinical cancer. Buenos Aires. Argentina: Centro Oncologico de Excelencia.