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Combined Modality Radioimmunotherapy For Non-Hodgkin's Lymphoma With Three Cycles Of 90Y-DOTA-Peptide-Lym-1, Paclitaxel and Cyclosporin A


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

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Trial Information

Combined Modality Radioimmunotherapy For Non-Hodgkin's Lymphoma With Three Cycles Of 90Y-DOTA-Peptide-Lym-1, Paclitaxel and Cyclosporin A


OBJECTIVES:

- Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody Lym-1 in
combination with paclitaxel and cyclosporine in patients with recurrent or refractory
non-Hodgkin's lymphoma.

OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody Lym-1 (Y90 MOAB
Lym-1).

Patients receive oral cyclosporine every 12 hours on days -2 to 14. Patients receive
unlabeled MOAB Lym-1 IV followed by a tracer dose of indium In 111 MOAB Lym-1 IV on day 0.
On day 7, patients receive unlabeled MOAB Lym-1 IV followed by Y90 MOAB Lym-1 IV. Patients
in cohorts 2-4 also receive paclitaxel IV over 3 hours on day 9. Courses repeat every 8
weeks for a total of 3 courses in the absence of disease progression or unacceptable
toxicity.

Cohorts of 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 preceding that at which 2 of 3
patients experience dose-limiting toxicity.

Patients are followed monthly for 3 months, every 3 months for 21 months, and then every 6
months for 3 years.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 36 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of non-Hodgkin's lymphoma (NHL) that has failed standard first-line
chemotherapy

- Measurable disease

- NHL tissue Lym-1 reactive in vitro

- Normocellular bone marrow as evidenced by less than 25% of the bone marrow being NHL
by bilateral bone marrow biopsy

- No bone marrow evidence of myelodysplastic syndrome

- HAMA titer negative

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- 3 to 6 months

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

- DLCO at least 50%

Other:

- No other prior malignancy within the past 5 years except for nonmelanoma skin cancer

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 4 weeks since prior external beam radiotherapy

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

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:

CDR0000068371

NCT ID:

NCT00009776

Start Date:

March 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