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Phase I Safety Study Of 131I-Lym-1 For The Treatment Of Previously Treated Diffuse Large B-Cell Lymphoma


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

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Trial Information

Phase I Safety Study Of 131I-Lym-1 For The Treatment Of Previously Treated Diffuse Large B-Cell Lymphoma


OBJECTIVES:

- Determine the maximum tolerated dose of iodine I 131 monoclonal antibody Lym-1 in
patients with previously treated diffuse large cell lymphoma.

- Determine the safety of this drug in these patients.

- Determine the response of patients to this drug.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive unlabeled monoclonal antibody Lym-1 IV over 40 minutes followed 15-30
minutes later by iodine I 131 monoclonal antibody Lym-1 IV over 2 minutes.

Cohorts of 3-6 patients receive escalating doses of iodine I 131 monoclonal antibody Lym-1
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting
toxicity.

Patients are followed weekly for 8 weeks and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 8-36 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed B-cell diffuse large cell lymphoma

- L-26 positive (i.e., CD20-positive)

- Failed 2 prior chemotherapy regimens

- At least 1 measurable lesion

- At least 2 cm by physical exam or CT scan

- No active lymphomatous meningitis or other CNS involvement by lymphoma

- No significant marrow involvement (i.e., more than 20% of hematopoietic marrow
elements from iliac crest biopsy)

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 3 months

Hematopoietic:

- WBC at least 3,500/mm3

- Granulocyte count at least 1,500/mm3

- Platelet count at least 125,000/mm3

Hepatic:

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- AST/ALT no greater than 3 times ULN

- Alkaline phosphatase no greater than 3 times ULN

Renal:

- Creatinine no greater than 2 times ULN

Cardiovascular:

- No electrocardial evidence of Q-wave myocardial infarction within the past 6 months

- No congestive heart failure

- No New York Heart Association class III or IV heart disease

Other:

- HIV negative

- Negative human anti-mouse antibodies (i.e., less than 74 ng/mL)

- No known antiplatelet antibodies

- No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior bone marrow or peripheral blood stem cell transplantation

- No prior radioimmunotherapy

- Prior unlabeled monoclonal antibody therapy allowed

- At least 120 hours since prior filgrastim (G-CSF) or sargramostim (GM-CSF)

- At least 1 month since prior epoetin alfa

Chemotherapy:

- See Disease Characteristics

- No concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Biologic therapy

- No prior total body irradiation (TBI)

- At least 6 months since prior radiotherapy (over 3,00 cGy) to more than 20% of
marrow-bearing space (i.e., pelvis and spine)

- No concurrent large-field radiotherapy (i.e., TBI, hemibody radiation, or radiation
fields that include more than 20% of active marrow to a dose of over 3,000 cGy)

- Concurrent localized radiotherapy is allowed to current or impending serious
complication (e.g., bronchial obstruction by hilar lymph nodes or impending fracture
due to lytic bone lesions)

Surgery:

- Not specified

Other:

- Recovered from prior anti-lymphoma therapy

- At least 120 hours since prior whole blood or platelet transfusion

- No concurrent anticoagulants or antiplatelet drugs

- No concurrent medications known to inhibit blood clotting or platelet aggregation
(e.g., aspirin)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Omer N. Koc, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069110

NCT ID:

NCT00028613

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Ireland Cancer CenterCleveland, Ohio  44106-5065