Combination Chemotherapy Plus Amifostine in Treating Patients With Metastatic or Unresectable Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003657
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: May 2006
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more that one drug may kill more tumor cells. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus amifostine chemoprotection in treating patients who have metastatic or unresectable cancer and who are undergoing peripheral stem cell transplantation.


Condition Intervention Phase
Bladder Cancer
Brain and Central Nervous System Tumors
Carcinoma of Unknown Primary
Extragonadal Germ Cell Tumor
Head and Neck Cancer
Kidney Cancer
Lung Cancer
Ovarian Cancer
Sarcoma
Testicular Germ Cell Tumor
Unspecified Adult Solid Tumor, Protocol Specific
Biological: filgrastim
Drug: amifostine trihydrate
Drug: carboplatin
Drug: etoposide
Drug: ifosfamide
Procedure: peripheral blood stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 25
Study Start Date: July 1998
Detailed Description:

OBJECTIVES: I. Describe the toxic effects of ifosfamide, carboplatin, and etoposide (ICE) with amifostine in patients with metastatic or locally unresectable malignancies who are undergoing peripheral stem cell transplantation. II. Describe the pharmacokinetic profile for ifosfamide and its metabolites in patients receiving the maximum tolerated dose of ICE with amifostine. III. Compare the toxic effects of this study with the toxic effects observed on protocol 94-078. IV. Compare the pharmacokinetics of ifosfamide on this study with the pharmacokinetics observed on protocol 94-078.

OUTLINE: Patients undergo peripheral blood stem cell (PBSC) harvest on day -8, followed by ifosfamide IV, carboplatin IV, and etoposide IV (ICE) by 96 hour continuous infusion on days -7 to -4. Patients receive amifostine IV twice a day on days -7 to -3. PBSCs are reinfused on day 0. Filgrastim (G-CSF) is administered subcutaneously beginning on day 0 at least 2 hours after infusion of the stem cells and continuing until blood cell counts recover. Patients are followed monthly for the first 2 months and then for survival.

PROJECTED ACCRUAL: A total of 25 evaluable patients will be accrued for this study within 19 months.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic or locally unresectable malignancy Patient may be responding to therapy: Stage IIIC/IV or recurrent/refractory ovarian carcinoma (ineligible for other bone marrow or stem cell transplant protocols) Recurrent or refractory germ cell carcinoma Extensive disease small cell lung cancer in partial or complete remission Stage IIIB non-small cell lung cancer responding to chemotherapy Sarcomas in or near complete remission after induction chemotherapy Responsive bladder, head and neck carcinoma, or carcinoma of unknown primary Other tumors without curative or first line therapy (not eligible for phase II or III studies) No active brain or bone marrow metastases

PATIENT CHARACTERISTICS: Age: 18 to 55 Performance status: PS 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT less than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance at least 60 mL/min Cardiovascular: No uncontrolled or severe cardiovascular disease No myocardial infarction within 6 months No congestive heart failure Other: Not pregnant No other serious medical or psychological illnesses No active uncontrolled bacterial, viral, or fungal infection No active duodenal ulcer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Greater than 3 weeks since prior chemotherapy See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Greater than 1 week since prior radiotherapy No concurrent radiotherapy Surgery: Greater than 1 week since prior surgery (except for biopsies) Other: No barbiturates, dilantin, or cimetidine within 3 weeks of high dose chemotherapy No antihypertensive medications within 24 hours prior to amifostine administration

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00003657

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Paul G.G. Richardson, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
Publications:
Elias AD, Richardson P, Tretyakov O, et al.: Amifostine with high dose infosfamide, carboplatin, and etoposide (ICE) with hematopoietic STEM cell support. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A197, 2000.

ClinicalTrials.gov Identifier: NCT00003657     History of Changes
Other Study ID Numbers: CDR0000066750, DFCI-98068, ALZA-97-038-ii, NCI-V98-1491
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
metastatic osteosarcoma
recurrent non-small cell lung cancer
chondrosarcoma
stage III adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
recurrent osteosarcoma
stage III bladder cancer
recurrent bladder cancer
stage IV bladder cancer
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
stage IIIB non-small cell lung cancer
unspecified adult solid tumor, protocol specific
classic Kaposi sarcoma
immunosuppressive treatment related Kaposi sarcoma
AIDS-related Kaposi sarcoma
recurrent Kaposi sarcoma
untreated metastatic squamous neck cancer with occult primary
recurrent metastatic squamous neck cancer with occult primary
ovarian stromal cancer
stage III ovarian germ cell tumor
stage IV ovarian germ cell tumor
recurrent ovarian germ cell tumor
stage III squamous cell carcinoma of the lip and oral cavity
stage III basal cell carcinoma of the lip

Additional relevant MeSH terms:
Head and Neck Neoplasms
Urinary Bladder Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Sarcoma
Lung Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Ovarian Neoplasms
Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Carcinoma
Neoplasms, Unknown Primary
Neoplasms
Neoplasms by Site
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Diseases
Neoplasms, Connective and Soft Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nervous System Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014