Dinaciclib in Treating Patients With Stage III-IV Melanoma

NCT01026324 | Terminated Phase 1 Results

• 5 other identifiers: NCI-2013-0052209-1528296U01CA062490P30CA006516
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I/II trial is studying the side effects and best dose of dinaciclib and to see how well it works in treating patients with advanced melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma

Outcome Measures

Primary Outcomes (2)

• Recommended Phase-2 Dose of SCH727965

  Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.

  14 days

• Percentage of Patients Alive (Phase II)

  Due to difficult accrual to the trial, enrollment was ended early without entering into Phase II

  Up to 1 year

Secondary Outcomes (1)

• Progression-free Survival

  Up to 6 months

Study Arms (1)

Treatment (dinaciclib)

EXPERIMENTAL

Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.

Drug: dinaciclib; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

dinaciclib DRUG

Given IV

Also known as: CDK inhibitor SCH 727965, cyclin-dependent kinase inhibitor SCH 727965, SCH 727965

Treatment (dinaciclib)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (dinaciclib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (dinaciclib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed, unresectable stage III or stage IV malignant melanoma
• ECOG performance status =\< 1
• Absolute neutrophil count \>= 1.5 x 10\^9/L
• Platelets \>= 100 x 10\^9/L
• Total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT =\< 1.5 x institutional upper limit of normal
• Creatinine =\< 1.5 mg/dl OR
• Creatinine clearance \>= 50 mL/min for patients with creatinine levels above institutional normal
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Eligible patients must agree to pre- and post-treatment biopsies of normal skin; in the phase 1 part of the study, patients with cutaneous disease or accessible lymph nodes must also agree to pre- and post-treatment tumor biopsies; in the phase 2 part of the study, tumor biopsies are required of the first 20 patients enrolled who have cutaneous disease or accessible lymph nodes
• Patients enrolled to the Phase 2 portion of the study must have measurable disease by RECIST criteria
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
• Patients may not be receiving any other investigational agents
• Patients with active CNS metastases are excluded; patients with a history of CNS metastases that have been treated must be stable for 4 weeks after completion of treatment, with image documentation required; patients must not be taking enzyme-inducing anticonvulsants and must be either off steroids or be receiving a stable dose of steroids
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with SCH727965
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with SCH727965; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
• Patients with other currently active malignancies are excluded, except those with an in-situ cancer or basal or squamous cell carcinoma of the skin
• In the phase 2 part of the study, patients who have received prior investigational treatment with a cdk inhibitor are excluded

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

dinaciclib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: F. Stephen Hodi, MD
• Organization: Dana-Farber Cancer Institute

stephen_hodi@dfci.harvard.edu

617-632-5053

Study Officials

• Frank Hodi

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 4, 2017
• Results First Posted: August 3, 2016

Record last verified: 2017-03

Locations

US (1)