• Return to search results
• Start new search

Investigator(s):
Alan Wayne, M.D. Principal Investigator Phone: 301-496-4256 waynea@mail.nih.gov
Referral Contact(s):
Pediatric Oncology  Phone: 1-877-624-4878 (Toll free)

---

Primary Eligibility:

• Histologically confirmed diagnosis of acute lymphoblastic leukemia (ALL) or non-Hodgkin’s lymphoma (NHL) including the following subtypes:
• Lymphoblastic lymphoma
• Burkitt’s lymphoma
• Large cell lymphoma
• Measurable or evaluable disease
• No isolated testicular or CNS leukemia
• Evidence of CD22-positive malignancy by one of the following criteria:
• ≥ 30% of malignant cells from a disease site CD22+ by flow cytometry analysis
• ≥ 15% of malignant cells from a disease site CD22+ by immunohistochemistry
• No active central nervous system (CNS) involvement; no CNS leukemia or lymphoma as manifested by any of the following:
• CSF WBC > 5 /µl and confirmation of CSF blasts
• Cranial neuropathies secondary to underlying malignancy
• Radiologically detected CNS lymphoma
• Patients must have relapsed or refractory disease and have received at least one standard chemotherapy and one salvage regimen
• No available alternative curative therapies; must be ineligible for a hematopoietic stem cell transplant (BMT), have refused BMT, or have disease activity that prohibits the time required to identify a suitable stem cell donor
• Relapse after prior autologous or allogeneic BMT is allowed
• No prior treatment with any pseudomonas-exotoxin-containing compound
• Last chemotherapy ≤ 2 weeks prior to starting study drug, with the following exceptions:
• There is no time restriction for intrathecal chemotherapy
• Corticosteroids or hydroxyurea are allowed provided there has been no increase in dose for at least 2 weeks prior to starting study drug
• ≥ 6 months and < 25 years of age
• Patients ≥ 12 years of age: ECOG score of 0–3
• Patients < 12 years of age: Lansky scale ≥ 40%
• Patients unable to walk because of paralysis, but who are up in a wheel chair, will be considered ambulatory for the purpose of calculating the performance score
• Not pregnant or nursing; patients of childbearing potential and their partners must use an approved method of contraception during the study
• Total bilirubin ≤ 2 mg/dL OR transaminases ≤ 5 x the upper limit of normal (ALT/AST) based on age and laboratory-specific normal ranges
• Normal age-adjusted serum creatinine (see below) or a creatinine clearance ≥ 60 mL/min/1.73 m²
• ≤ 5 years of age: maximum serum creatinine 0.8 mg/dL
• > 5 and ≤ 10 years of age: maximum serum creatinine 1 mg/dL
• > 10 and ≤ 15 years of age: maximum serum creatinine 1.2 mg/dL
• > 15 years of age: maximum serum creatinine 1.5 mg/dL
• ANC ≥ 1,000/cmm, or platelet count ≥ 50,000/cmm for non-leukemic patients only (cytopenias due to disease, based on the results of bone marrow, not an exclusion)
• HIV negative
• No active hepatitis B or C infection
• No medical condition that would preclude study participation
• No second malignancy other than non-basal cell carcinoma of the skin or in situ carcinoma of the cervix, unless the tumor was treated with curative intent ≥ 2 years previously and patient is in remission

---

Treatment Plan:

This is a phase I single-institution trial of intravenous (IV) CAT-8015.

• Patients receive CAT-8015 IV every other day for 6 doses
• Cycles may be repeated every 21 days
• Cohorts of 3 to 6 patients will be accrued at each dose level starting at 5 mcg/kg every other day for 6 doses

---

Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 11/11/08
Updated: 1/5/09