Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT00059995
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed B-cell or T-cell lymphoma
* Hodgkin's lymphoma and anaplastic large cell lymphoma eligible
* No HIV-associated lymphoma
* CD30-positive disease by biopsy, flow cytometry, or immunohistochemistry
* At least 50% of malignant cells (specifically Reed-Sternberg cells for Hodgkin's lymphoma) must express CD30
* Must meet one of the following criteria for relapsed/refractory disease:
* Relapsed after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate)
* Relapsed disease must be within the prior irradiated field
* Disease that is refractory to prior chemotherapy or radiotherapy with no other curative treatment option
* Disease progression must be within the prior irradiated field
* Progressive and evaluable disease (measurable disease required for patients accrued on study after the maximum tolerated dose is determined)
PATIENT CHARACTERISTICS:
Age
* Over 12
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* WBC at least 1,500/mm\^3\*
* Neutrophil count at least 1,000/mm\^3\*
* Platelet count at least 75,000/mm\^3\*
* Hemoglobin at least 8.0 g/dL\* NOTE: \*Laboratory abnormalities attributable to organ involvement by lymphoma are allowed
Hepatic
* AST no greater than 2 times upper limit of normal (ULN)\*
* Bilirubin no greater than 2.0 mg/dL (unless due to Gilbert's syndrome)\*
* Hepatitis B surface antigen negative
* Hepatitis C antibody negative NOTE: \*Laboratory abnormalities attributable to organ involvement by lymphoma are allowed
Renal
* Creatinine no greater than 2 times ULN\* NOTE: \*Laboratory abnormalities attributable to organ involvement by lymphoma are allowed
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 9 months after study participation
* HIV negative
* No other active malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No active significant infection
* No apparent opportunistic infection, as indicated by any of the following:
* Purified protein derivative recently determined to be positive
* Infectious infiltrate by chest x-ray
* Recent changes in fever/chill patterns
* New, unexplained neurological symptoms
* No underlying medical condition that would preclude receiving study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* No prior anti-CD30 antibody therapy
* No other concurrent biologic therapy
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* No concurrent systemic steroidal therapy (excluding physiologic doses)
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery
* Not specified
Other
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00059995
Study Brief:
Protocol Section:
NCT00059995