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Monoclonal Antibody Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma - Article


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HIV Antibody




Clinical Trial: Monoclonal Antibody Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma

This study is no longer recruiting patients.

Sponsored by: University of California Davis Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy, cyclosporine, and paclitaxel followed by peripheral stem cell transplantation in treating patients who have refractory non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
Burkitt's Lymphoma
Lymphoblastic Lymphoma
Myeloid Leukemia
 Procedure: chemotherapy
 Procedure: biological response modifier therapy
 Procedure: radiation therapy
 Procedure: non-specific immune-modulator therapy
 Procedure: isotope therapy
 Procedure: monoclonal antibody therapy
 Procedure: colony-stimulating factor therapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: antibody therapy
 Procedure: cytokine therapy
 Procedure: radioimmunotherapy
 Drug: bone marrow ablation with stem cell support
 Drug: cyclosporine
 Drug: filgrastim
 Drug: indium In 111 monoclonal antibody Lym-1
 Drug: monoclonal antibody Lym-1
 Drug: paclitaxel
 Drug: yttrium Y 90 monoclonal antibody Lym-1
Phase I

MedlinePlus related topics:  Bone Marrow Diseases;   Cancer;   Cancer Alternative Therapy;   Immune System and Disorders;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphatic Diseases;   Lymphoma;   Viral Infections

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Yttrium Y 90 Monoclonal Antibody Lym-1, Cyclosporine, and Paclitaxel Followed By Autologous Peripheral Blood Stem Cell Transplantation in Patients With Refractory Non-Hodgkin's Lymphoma

Further Study Details: 

Study start: February 2001

OBJECTIVES: I. Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody Lym-1 administered with cyclosporine and paclitaxel followed by autologous peripheral blood stem cell transplantation in patients with refractory non-Hodgkin's lymphoma. II. Determine the toxicity of this treatment regimen in these patients.

PROTOCOL OUTLINE: This is an open-label, dose escalation study of yttrium Y 90 monoclonal antibody Lym-1 (Y90 MOAB Lym-1). Patients are assigned to one of four cohorts. Cohort I: Patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 4 days prior to peripheral blood stem cell (PBSC) mobilization and continuing until adequate PBSC are collected. Patients receive unlabeled monoclonal antibody (MOAB) Lym-1 IV followed by a tracer dose of indium In 111 MOAB Lym-1 (In111 MOAB Lym-1) IV on day 0 and unlabeled MOAB Lym-1 IV followed by Y90 MOAB Lym-1 IV on day 7. Patients also receive oral cyclosporine every 12 hours on days -2 to 14. Patients may undergo autologous PBSC transplantation, if necessary, no earlier than day 17 and receive G-CSF SC beginning at the completion of PBSC re-infusion and continuing until blood counts recover. Cohort II: Patients undergo PBSC mobilization and receive treatment as in cohort I. Patients also receive paclitaxel IV over 3 hours on day 9. Cohort III: Patients undergo PBSC mobilization and receive unlabeled MOAB Lym-1, In111 MOAB Lym-1, Y90 MOAB Lym-1, and cyclosporine as in cohort I and paclitaxel as in cohort II. Patients undergo autologous PBSC transplantation no earlier than day 17. Patients receive G-CSF after transplantation as in cohort I. Cohort IV: Patients undergo PBSC mobilization and receive treatment as in cohort III. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 1 to 3 patients receive escalating doses of Y90 MOAB Lym-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 3 patients require PBSC transplantation, or the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity. Patients are followed monthly for 3 months, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study within 36 months.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Histologically confirmed non-Hodgkin's lymphoma (NHL) that has failed standard therapy

Measurable disease

HAMA titer negative

NHL tissue Lym-1 reactive in vitro

Bilateral bone marrow biopsy less than 25% NHL

No evidence of myelodysplastic syndrome in bone marrow

A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

--Prior/Concurrent Therapy--

Biologic therapy: Not specified

Chemotherapy: At least 4 weeks since prior chemotherapy

Endocrine therapy: Not specified

Radiotherapy:

  • No prior radiotherapy involving more than 25% of bone marrow
  • At least 4 weeks since prior external beam radiotherapy

Surgery: Not specified

--Patient Characteristics--

Age: 18 and over

Performance status: Karnofsky 70-100%

Life expectancy: Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 130,000/mm3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • AST no greater than 84 U/L

Renal:

  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance at least 50 mL/min

Cardiovascular: LVEF at least 50%

Pulmonary:

  • FEV1 at least 60% predicted
  • FVC at least 60% predicted
  • Corrected DLCO at least 50%

Other:

  • No other malignancy within the past 5 years except for non- melanoma skin cancer
  • HIV negative
  • No AIDS
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Location Information


California
      University of California Davis Cancer Center, Sacramento,  California,  95817,  United States

Study chairs or principal investigators

Robert T. O'Donnell,  Study Chair,  University of California Davis Cancer Center   

More Information

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

Study ID Numbers:  CDR0000068363; UCD-991860; NCI-V00-1638
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00008021
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 1, 2008



Page Updated: June 1, 2005
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