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A Phase I Clinical Trial of Radiolabeled Immunotherapy With Humanized LL2 in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-Hodgkins Lymphoma

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Trial Information

A Phase I Clinical Trial of Radiolabeled Immunotherapy With Humanized LL2 in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma


Disease Characteristics:

- Patients with a documented histologic or cytologic diagnosis of B-cell NHL.

- Patients who have failed at least one regimen of chemotherapy and are not eligible
for any alternate therapies of higher therapeutic priority.

- Patients with at least one measurable tumor site > 1.5 cm in at least one dimension.

Prior/Concurrent Therapy:

- Chemotherapy: Patients must have failed standard therapy or are not eligible for any
alternate therapies of higher therapeutic priority.

- Biologic Therapy: Patients who have received human or humanized monoclonal antibodies
will be eligible provided pre-study evaluations demonstrate no significant reactivity
with hLL2 IgG (i.e., HAHA).

- Radiotherapy: No prior radiation therapy to >25% of the bone marrow. No prior
radiation to maximal tolerable levels for any critical organ (e.g., 2,000 cGy for the
lungs and kidneys). Patients who have had whole pelvic irradiation are not eligible.

Patient Characteristics/

Inclusion Criteria:



- Age Range: Male or Female at least 18 years of age

- Performance Status: Patients with a Karnofsky performance status > 60% (or
equivalent, ECOG 0-2) and expected survival of at least 12 weeks.

- Hematopoietic: Hemoglobin > 10 g/dL; ANC > 1.5x10^9/L; Platelets > 100x10^9/L;

- Hepatic: Serum bilirubin < 2.0 mg/dL; AST and ALT < 2 x ULN w/o liver metastases or
<5 x ULN w/liver metastases

- Renal: Creatinine < 2.0 mg/dL

- Cardiovascular: Patients with LVEF >/= 50% by MUGA or 2D-ECHO.

- Pulmonary: Patients with DFCO and FEV1 >/= 60% by required Pulmonary Function Tests.

- Other: Patients agreeing to use a medically effective method of contraception while
enrolled in the study. A pregnancy test will be performed on each premenopausal
female of childbearing potential immediately prior to entry into the study. Patients
able to understand and give written informed consent.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

IM-T-hLL2-14

NCT ID:

NCT00054834

Start Date:

March 2003

Completion Date:

Related Keywords:

  • Non-Hodgkins Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111