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Completed

NCT Number: NCT00003657

High-dose ICE With Amifostine

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.

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Key information

Conditions

Bladder Cancer AIDS-related Kaposi sarcoma Adnexal Diseases Brain and Central Nervous System Tumors Bronchial Neoplasms Carcinoma Carcinoma of Unknown Primary Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Ovarian Epithelial Carcinoma, Squamous Cell Central Nervous System Neoplasms Chondrosarcoma Cranial Nerve Diseases DNA Virus Infections Endocrine Gland Neoplasms Endocrine System Diseases Esthesioneuroblastoma, Olfactory Extragonadal Germ Cell Tumor Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Herpesviridae Infections Infections Kidney Cancer Kidney Diseases Kidney Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Unknown Primary Neoplasms, Vascular Tissue Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Olfactory Nerve Diseases Osteosarcoma Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Sarcoma, Kaposi Small Cell Lung Carcinoma Squamous Cell Carcinoma of Head and Neck Testicular Diseases Testicular Germ Cell Tumor Testicular Neoplasms Thoracic Neoplasms Unspecified Adult Solid Tumor, Protocol Specific Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

filgrastim

Biological

Amifostine

Drug

Other names: Ethyol®

carboplatin

Drug

Other names: Paraplatin

etoposide

Drug

Other names: Toposar, VePesid, Etopophos

ifosfamide

Drug

Other names: Ifex

peripheral blood stem cell transplantation

Procedure

Primary outcomes

  1. Percentage of Participants with Grade 2 or higher renal toxicities

    Time frame: 2 Months

Secondary outcomes

  1. Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine

    Time frame: 2 Months

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection

Important dates

Study start
1998
Primary completion
2000
Study completion
2002
First posted
Mar 31, 2004
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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