Biological Therapy Following Surgery in Treating Patients With Stage III or Stage IV Kidney Cancer
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Purpose
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery in treating patients who have stage III or stage IV kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: aldesleukin Biological: autologous tumor cell vaccine Biological: muromonab-CD3 Biological: therapeutic autologous lymphocytes Procedure: surgical procedure |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Immunotherapy for Renal Cell Carcinoma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy |
| Study Start Date: | June 1997 |
| Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Evaluate the efficacy of immunotherapy with irradiated autologous tumor cell vaccine and sargramostim (GM-CSF) followed by monoclonal antibody OKT3- activated T lymphocytes and interleukin-2 in combination with surgery in terms of response rate in patients with stage III or IV renal cell carcinoma.
- Determine the immunogenicity of renal cell carcinoma in this patient population.
OUTLINE: Patients are stratified according to extent of disease, extent of antigen specific response to vaccination, performance status (0 vs 1), prior therapy (yes vs no), and gender.
Patients undergo surgical debulking of tumor on week 1 followed by adjuvant chemotherapy. Within 2-4 weeks of chemotherapy, patients are vaccinated with irradiated autologous tumor cells and sargramostim (GM-CSF), then receive GM-CSF alone intradermally at vaccination sites daily for 4 days. Patients are revaccinated 2 weeks later.
Patients undergo peripheral blood mononuclear cell collection two weeks after the second vaccination. Peripheral blood mononuclear cells are stimulated with anti-CD3 monoclonal antibody (OKT3) and interleukin-2, producing activated T lymphocytes. The activated T lymphocytes are infused IV over 1-6 hours followed by 5 doses of interleukin-2 IV every other day over 10 days. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients may receive one additional course of immunotherapy as above.
Patients are followed every 3 months for 2 years, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically proven stage III or IV renal cell carcinoma
- Resectable disease
- At least 50,000,000 viable cells obtained from surgical specimen for use in the immunization part of this study
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- SWOG 0 or 1
Life expectancy:
- At least 6 months
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least lower limit of normal
- No active or recent uncontrolled bleeding
Hepatic:
- Bilirubin normal
- SGOT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)
Renal:
- Creatinine normal
Other:
- Negative stool guaiac
- No impaired immunity
- No uncontrolled diabetes
- No active uncontrolled infections
- No other serious disease
- No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
- At least 2 weeks since prior therapy and recovered
Contacts and Locations| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| Study Chair: | Roy D. Baynes, MD, PhD, FACP | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004023 History of Changes |
| Other Study ID Numbers: | CDR0000067242, WSU-C-1403-RN, NCI-G99-1566 |
| Study First Received: | November 1, 1999 |
| Last Updated: | September 24, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
Muromonab-CD3 Aldesleukin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Antineoplastic Agents Therapeutic Uses Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 23, 2013