October 2012: Trials in Progress

Published Online: Thursday, October 18, 2012
The Trials in Progress section is intended to stimulate discussion about ongoing clinical trials and to promote collaboration across the oncology community. Each month, OBTN will present summaries of ongoing research in a broad range of cancer types.

Ovarian Cancer

Solo ipilimumab for recurrent platinum-sensitive ovarian cancer

This phase II study will examine the use of ipilimumab monotherapy after completion of chemotherapy in recurrent platinum-sensitive ovarian cancer patients with an ECOG performance status of 0 or 1 and residual measurable disease. The primary outcome measure is the incidence of drug-related adverse events of grade 3 or higher during the induction period of ipilimumab. An intravenous solution of 10 mg/kg of ipilimumab will be administered once every 3 weeks for 4 doses, and then once every 12 weeks starting at week 24 until the onset of disease progression or unacceptable toxicity. The estimated enrollment is 40 patients. Women who have platinum-refractory ovarian cancer or who have had more than four lines of prior therapy are ineligible.

Sponsor: Bristol-Myers Squibb

ClinicalTrials.gov Identifier: NCT01611558


MM-121 plus paclitaxel in platinum-resistant/refractory advanced ovarian cancer

This phase II study will compare MM-121 combined with paclitaxel versus paclitaxel alone in patients with locally advanced/ metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have received at least one prior platinum-based chemotherapy regimen and are platinum-resistant/refractory. For inclusion, patients must also be eligible for weekly paclitaxel. MM-121 is an investigational fully human monoclonal antibody that targets the ErbB3 receptor. The primary outcome measure is progression-free survival (PFS). The investigators aim to recruit about 210 women and hope to complete their study by April 2015.

Sponsor: Merrimack Pharmaceuticals

ClinicalTrials.gov Identifier: NCT01447706


Skin Cancer

T-VEC versus GM-CSF for advanced melanoma

This phase III study will compare talimogene laherparepvec (T-VEC) versus subcutaneous GM-CSF for the treatment of patients with unresectable stage IIIb, IIIc, and IV melanoma stratified by typical prognostic factors. T-VEC is an oncolytic HSV1 that selectively replicates in tumors with a proposed mechanism of action involving lytic destruction of injected tumors and induction of a systemic antitumor immune response enhanced by local GM-CSF expression. Patients will be randomized in a 2:1 ratio to T-VEC (priming dose of up to 4 x 106 pfu intratumorally, then 3 weeks later by up to 4 x 108 pfu every 2 weeks) or GM-CSF subcutaneously 125 μg/m2 daily for 14 days every 28 days. Study participants must have ECOG status of 0-1 and at least one injectable cutaneous, subcutaneous, or nodal tumor. The primary endpoint is durable response rate, defined as a complete or partial response continuously maintained for at least 6 months that started within 12 months of treatment initiation. The sole secondary endpoint is overall survival (OS).

Sponsor: Amgen

ClinicalTrials.gov Identifier: NCT00769704


Sulforaphane for atypical nevi precursor lesions

This study will evaluate sulforaphane as a possible nutritional chemopreventive agent for modulating key steps in melanoma progression and the expression of signal transducer and activator of transcription proteins in melanocytic and stromal elements of atypical nevi. Sulforaphanes are bioactive cruciferous compounds rich in the Brassica family, especially broccoli sprouts; topical broccoli sprout extracts reduce ultraviolet radiation (UVR) erythema response in human skin, and may protect against UVR DNA damage. Melanoma patients with more than two atypical nevi will receive oral broccoli sprout extract rich in sulforaphane at dosages of 50 μmol, 100 μmol, or 200 μmol daily for 28 days. Subjects must avoid dietary glucosinolates and isothiocyanates throughout the study and maintain food diaries. Blood samples, photography of index atypical nevi, and biopsies of selected atypical nevi and normal skin will be analyzed for changes in atypia, sulforaphane localization histopathology, and STAT 1/3 expression in the nevi and skin harvested at baseline and at study completion.

Sponsor: John Kirkwood, MD, University of Pittsburgh

ClinicalTrials.gov Identifier: NCT01568996


Breast Cancer

Denosumab as adjuvant treatment for high-risk, early-stage breast cancer

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