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	Treatment or Intervention	Phase
Lung Cancer Gastrointestinal Cancer Reproductive Cancers Head and Neck Cancer Bone Cancer Kaposi's Sarcoma Soft Tissue Sarcoma	Drug: amifostine  Drug: carboplatin  Drug: etoposide  Drug: filgrastim  Drug: ifosfamide	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years   -   55 Years

Criteria

PROTOCOL ENTRY 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

--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

--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

Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States

Study chairs or principal investigators

Paul Gerard Guy Richardson,  Study Chair,  Dana-Farber/Harvard Cancer Center   

Study ID Numbers:  CDR0000066750; DFCI-98068; NCI-V98-1491; ALZA-97-038-ii
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003657
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08