Clinical Trial: High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer

This study is no longer recruiting patients.

Sponsored by: University of Kentucky
Information provided by: National Cancer Institute (NCI)


RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of high-dose melphalan plus peripheral stem cell transplantation and amifostine in treating patients with cancer.

Condition Treatment or Intervention Phase
Bone Cancer
ovarian sarcoma
ovarian epithelial cancer
Breast Cancer
Multiple Myeloma
 Drug: amifostine
 Drug: cyclophosphamide
 Drug: filgrastim
 Drug: melphalan
Phase I
Phase II

MedlinePlus related topics:  Bone Cancer;   Breast Cancer;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma;   Multiple Myeloma;   Ovarian Cancer;   Soft Tissue Sarcoma
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Educational/Counseling/Training

Official Title: Phase I/II Study of High Dose Melphalan with Autologous Peripheral Blood Stem Cell Support and Amifostine Cytoprotection in Cancer Patients

Further Study Details: 

Study start: July 1999

OBJECTIVES: I. Determine the maximum tolerated dose of high dose melphalan with autologous peripheral blood stem cell support and amifostine cytoprotection in patients with cancer. II. Determine the complete response rate, event free survival, overall survival, and nonrelapse mortality in this patient population.

PROTOCOL OUTLINE: This is a dose escalation study of melphalan. Prior to high dose melphalan and amifostine cytoprotection, patients may receive cyclophosphamide IV. Filgrastim (G-CSF) is given until cytapheresis is completed. Patients receive high dose melphalan according to an escalating dose schedule. High dose melphalan is administered IV on day -1. Amifostine is also administered on days -2 and -1. Peripheral blood stem cell transplantation is performed on day 0. Dose escalation of high dose melphalan continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose limiting toxicity. After the MTD of high dose melphalan is determined, additional patients are treated at this dose level. Patients are followed at days 30, 100, 365, and yearly thereafter.

PROJECTED ACCRUAL: After the determination of MTD, a total of 14-25 patients will be accrued for this study.


Ages Eligible for Study:  14 Years   -   70 Years



--Disease Characteristics--

  • Confirmed diagnosis of primary tumor and/or recurrence that has a low curative potential using other therapies, including but not limited to: Acute leukemia; Myeloma; Breast cancer; Ovarian cancer; Hodgkin's disease; Non-Hodgkin's lymphoma; Neuroblastoma; Ewing's sarcoma
  • In the absence of recurrence, malignancies for which an autotransplant regimen is considered a reasonable therapeutic alternative are also considered
  • Greater than 25% of bone marrow normal cellularity and less than 10% of volume composed of tumor cells
  • No active brain metastases or carcinomatous meningitis (controlled CNS metastases eligible)

--Prior/Concurrent Therapy--

  • Biologic therapy: No more than 1 prior autologous peripheral blood stem cell transplant
  • Chemotherapy: Cumulative anthracycline or equivalent dose no greater than 450 mg/m2
  • Endocrine therapy: Not specified
  • Radiotherapy: Not specified
  • Surgery: Not specified
  • Other: Recovered from prior therapy; No antihypertensives during and 24 hours prior to amifostine administration

--Patient Characteristics--

  • Age: 14 to 70
  • Performance status: ECOG 0-2
  • Life expectancy: Not specified
  • Hematopoietic: WBC greater than 3000/mm3; Absolute neutrophil count greater than 1500/mm3; Platelet count greater than 100,000/mm3
  • Hepatic: Bilirubin, SGOT, and SGPT less than 2 times normal
  • Renal: Creatinine clearance greater than 60 mL/min
  • Cardiovascular: LVEF at least 45%
  • Pulmonary: DLCO at least 50% FEV1 at least 60%
  • Other: Not pregnant or nursing; Fertile patients must use effective contraception; HIV, HTLV-1, and HTLV-2 negative; Hepatitis B and C negative

Location Information

      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States

      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States

      Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107-5541,  United States

      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States

Study chairs or principal investigators

Donna E. Reece,  Study Chair,  University of Kentucky   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066448; UKMC-97BMT72; NCI-V98-1455; ALZA-UKMC-97BMT72
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999 Identifier:  NCT00003425
Health Authority: Unspecified processed this record on 2005-04-08

Cache Date: April 9, 2005