Know Cancer

or
forgot password

Phase I Trial of Humanized 1D10 Monoclonal Antibody (Hu1D10) In Patients With Relapsed Non-Hodgkin's Lymphoma (NHL)


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Phase I Trial of Humanized 1D10 Monoclonal Antibody (Hu1D10) In Patients With Relapsed Non-Hodgkin's Lymphoma (NHL)


OBJECTIVES:

I. Assess the safety and tolerability of monoclonal antibody Hu1D10 in patients with
previously treated non-Hodgkin's lymphoma expressing the antigen recognized by Hu1D10.

II. Determine the maximum tolerated dose of monoclonal antibody Hu1D10 in these patients.

III. Evaluate the pharmacokinetics, compare the pharmacology at different dose levels, and
determine the optimal biological dose of this drug in these patients.

IV. Evaluate any antilymphoma effects of this drug in these patients.

OUTLINE: This is a dose escalation, multicenter study.

Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1, 8, 15, and 22.
Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts
of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6
patients experience dose limiting toxicity. Once the MTD is determined, an additional cohort
of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5.

Patients are followed at 4 weeks, 50 days, and periodically thereafter until disease
progression.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed non-Hodgkin's lymphoma in relapse or refractory to prior
treatment

- At least 50% of malignant cells on biopsy specimen reactive with the 1D10 antibody OR
at least 50% of B cells within tumor reactive with 1D10 if extensive T cell
infiltrations present

- Measurable or evaluable disease

- Circulating tumor cells fewer than 5,000/mm3 (in dose escalation phase only)

- Not eligible for curative conventional therapy

PATIENT CHARACTERISTICS:

- Age: 18 and over

- Performance status: ECOG 0-2

- Life expectancy: At least 3 months

- Platelet count at least 75,000/mm3

- Bilirubin less than 2.5 mg/dL

- SGOT less than 3 times upper limit of normal

- Creatinine less than 2.0 mg/dL

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

- No clinically significant pulmonary disease

- No active serious infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception HIV negative

PRIOR CONCURRENT THERAPY:

- At least 4 weeks since prior interferon

- Concurrent transfusions allowed

- At least 4 weeks since prior cytotoxic chemotherapy

- No concurrent antineoplastic agents

- At least 4 weeks since prior corticosteroids

- No concurrent glucocorticoids

- At least 4 weeks since prior radiotherapy

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Brian Link, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Holden Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067318

NCT ID:

NCT00004101

Start Date:

November 1999

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

Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Biologics Evaluation SectionBethesda, Maryland  20892-9903