Dinaciclib in Treating Patients With Stage IV Melanoma - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00937937

Purpose

RATIONALE: Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects and how well dinaciclib works in treating patients with stage IV melanoma.

Condition	Intervention	Phase
Melanoma (Skin)	Drug: dinaciclib	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Trial of SCH 727965 (NSC 727135) in Patients With Stage IV Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

1-year overall survival [ Designated as safety issue: No ]
6-month progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complete and partial response rate [ Designated as safety issue: No ]
Safety as per NCI CTCAE v.3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	July 2009
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To assess the 1-year overall survival rate in patients with stage IV melanoma treated with dinaciclib.

Secondary

To assess the 6-month progression-free survival rate in these patients.
To evaluate the response rate (confirmed and unconfirmed complete and partial responses) in the subset of patients with measurable disease.
To assess the safety and tolerability of dinaciclib given to patients with stage IV melanoma.

OUTLINE: This is a multicenter study.

Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for up to 3 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Biopsy-confirmed malignant melanoma
- Stage IV disease
- Cutaneous or mucosal origin
- Melanoma of unknown primary allowed
- No ocular melanoma
Measurable or non-measurable disease
No prior or concurrent brain metastases as confirmed by CT scan or MRI

PATIENT CHARACTERISTICS:

Zubrod performance status 0-1
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9 g/dL
Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (including patients with hepatic metastases)
SGOT or SGPT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastases)
Serum creatinine ≤ 1.5 times ULN
Not pregnant or nursing
Fertile patients must use effective contraception
No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

No prior therapy with a cyclin-dependent kinase inhibitor
At least 14 days since prior radiotherapy
At least 28 days since prior systemic chemotherapy
At least 28 days since prior adjuvant systemic therapy
At least 28 days since prior surgery
No more than 1 prior systemic therapy regimen (chemotherapy, biologic/immunotherapy, hormonal therapy, or a combination regimen) for stage IV melanoma and any side effects must have resolved to ≤ grade 1
Any number of prior adjuvant systemic therapy regimens allowed, including interferon alfa-2b, GM-CSF, chemotherapy, and chemobiotherapy
- Therapy for stage IV resected free-of-disease will be considered adjuvant therapy
Prior radiotherapy allowed provided any side effects have resolved to ≤ grade 1
Prior surgery (for both the primary and stage IV disease) allowed provided side effects have resolved to ≤ grade 1
No other concurrent or planned non-study treatment (including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy)
No concurrent CYP3A4 inhibitors or inducers
No concurrent grapefruit or grapefruit juice

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937937

Show 167 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Christopher D. Lao, MD, MPH

University of Michigan Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker )
Study ID Numbers:	CDR0000647155, SWOG-S0826
Study First Received:	July 10, 2009
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00937937 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IV melanoma
recurrent melanoma
acral lentiginous malignant melanoma
lentigo maligna malignant melanoma

mucosal melanoma
nodular malignant melanoma
superficial spreading malignant melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on February 08, 2010