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A Phase I Study of 90Y-DOTA-Peptide-Lym-1 With Peripheral Blood Stem Cell Support, Paclitaxel And Cyclosporin A In Patients With Non-Hodgkin's Lymphoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

A Phase I Study of 90Y-DOTA-Peptide-Lym-1 With Peripheral Blood Stem Cell Support, Paclitaxel And Cyclosporin A In Patients With Non-Hodgkin's Lymphoma


OBJECTIVES:

- 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.

- Determine the toxicity of this treatment regimen in these patients.

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

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

- Any grade allowed

- Intermediate or high grade NHL must have failed standard therapy with curative
intent

- 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 NOTE: 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.

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 130,000/mm^3

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% of predicted

- FVC at least 60% of 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

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Gerald L. DeNardo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis

Authority:

United States: Federal Government

Study ID:

CDR0000068363

NCT ID:

NCT00008021

Start Date:

February 2001

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

University of California Davis Cancer CenterSacramento, California  95817