High-dose ICE With Amifostine

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 2

Conditions: Carcinoma of Unknown Primary; Sarcoma; Brain and Central Nervous System Tumors; Bladder Cancer; Unspecified Adult Solid Tumor, Protocol Specific; Extragonadal Germ Cell Tumor; Lung Cancer; Kidney Cancer; Ovarian Cancer; Head and Neck Cancer; Testicular Germ Cell Tumor

Treatments: Drug: Carboplatin; Drug: Etoposide; Drug: Ifosfamide; Biological: filgrastim; Drug: Amifostine; Procedure: peripheral blood stem cell transplantation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003657

P30CA006516 (U.S. NIH Grant/Contract)

ALZA-97-038-ii

98-068

DFCI-98068

NCI-V98-1491

Details and patient eligibility

About

The purpose of the study is to evaluate the combination of amifostine and high dose chemotherapy with blood stem cell support. Amifostine is a druf developed to protect normal tissues against the toxicities of chemotherapy and radiotherapy and has reduced the side effects of chemotherapy given at conventional doses.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria:

• Histologically documented malignancy

• Metastatic or locally unresectable malignancy

• Patient may be responding to therapy

  • Responding Stage IIIC/IV or recurrent/refractory ovarian carcinoma (ineligible for other bone marrow or stem cell transplant protocols)
  • Relapsed germ cell carcinomas
  • Relapsed lymphomas (ineligible for other BMT or SCT protocols
  • SCLC in PR or CR
  • Sarcomas in or near complete remission after induction chemotherapy
  • Stage IIIB NSCLC responding to 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)

• Aged 18 to 55 Physiologic years

  -- Performance status: PS 0-1

• Prior Treatment

  • > 1 week since surgery or RT
  • > 3 weeks since prior CT

• Informed Consent

• Required initial laboratory data:

  • White Cell Count Life ≥ 3000/ul

  • Platelet Count ≥ 100,000/ul

  • Creatinine ≤ 1.5 x normal

  • Bilirubin ≤ 1.5 x normal

  • No current metastases

    • BM Asp & Bx
    • Brain CAT

  • Creatinine Clearance ≥ 60 cc/min

  • SGOT < 2.5 x normal

• No other serious medical or psychiatric illness which would prevent informed consent or general anesthesia

  • Uncontrolled or severe cardiovascular disease including recent (< 6 months) myocardial infarction, or congestive heart failure
  • Active uncontrolled bacterial, viral, or fungal infection; or an active duodenal ulcer; until these conditions are corrected or controlled
  • Pregnancy
  • Unable to stop taking antihypertensive medication 24 hours prior to administration of Ethyol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

High Dose ICF with Amifostine

Experimental group

Description:

* Patients undergo peripheral blood stem cell transplantation (PBSC) harvest on day -8, * ifosfamide IV, carboplatin IV 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.

Treatment:

Drug: Amifostine

Drug: Ifosfamide

Procedure: peripheral blood stem cell transplantation

Drug: Etoposide

Drug: Carboplatin

Biological: filgrastim