A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies

Trial ID or NCT#

NCT00649584

Status

not recruiting iconNOT RECRUITING

Purpose

This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.

Official Title

A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies

Eligibility Criteria

Ages Eligible for Study: Older than 12 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Histologically confirmed CD30-positive hematologic malignancy.* Patients with HL must have failed systemic chemotherapy.* Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.* Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique.
Exclusion Criteria:
  1. * Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).* History of allogeneic stem cell transplant.* Patients who have had previous treatment with any anti-CD30 antibody.
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Investigator(s)

Sandra Horning

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Contact

Euodia Jonathan
6507256432

View on ClinicalTrials.gov