Symptoms and General Pathology

All Conditions

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Recurrence

Melanoma

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Hutchinson's Melanotic Freckle

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Neoplasms by Histologic Type

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Nevus, Pigmented

Nevus

Nevi and Melanomas

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Lentigo Maligna Melanoma

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Superficial Spreading Melanoma

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Neuroendocrine Tumor

Neuroepithelioma

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

Dinaciclib

Christopher D Lao

This phase II trial is studying the side effects and how well dinaciclib works in treating patients with stage IV melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. To assess the 6-month progression-free survival rate in these patients. II. To evaluate the response rate (confirmed and unconfirmed complete and partial responses) in the subset of patients with measurable disease.

III. 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.

Dinaciclib in Treating Patients With Stage IV Melanoma

A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The duration from the date of randomization to the date of first documentation of progressive disease, symptomatic deterioration, or death dure to any cause.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The outcome measure here is different from Serious Adverse Event, whose definition could be more strict and specific. The number of patients who suffers the certain adverse event listed here could be larger than the number listed in following serious adverse event.

National Cancer Institute (NCI)

SCH 727965

The median ans full range of those 72 patients' ages.

Age, Continuous

The gender summary of those 72 patients who have received Dinaciclib.

Sex: Female, Male

White

Asian

Pacific Islander

The race summary of 72 patients who have received Dinaciclib.

Race/Ethnicity, Customized

Unknown

The hispanic or non-hispanic summary of 72 patients who have received Dinaciclib.

Hispanic

The performance status of 72 patients who have received Dinaciclib. Only performance status 0 or 1 are included in the study.

Performance status 0: Fully active, able to carry on all pre-disease performance without restriction.

Performance status 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

The higher score, the worse outcomes.

Performance Status

Bone

Brain

Liver

Lymph node, soft tissue, skin

Lung

Other visceral

Other non-visceral

Sites of metastases of 72 patients who have received Dinaciclib.

Site(s) of Metastases

Whether elevated LDH or not of 72 patients who have received Dinaciclib.

Elevated LDH

Cutaneous

Mucosal

Unknown primary

Primary type of melanoma of 72 patients who have received Dinaciclib.

Primary Type

Include all the patients that have received the treatment and been adverse event evaluable.

Melanoma Committee Statistician

Overall Survival

Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)

Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) Assessed by RECIST

AST, SGOT

Cardiac troponin I (cTnI)

Cardiac-ischemia/infarction

Constitutional Symptoms-Other (Specify)

Dehydration

Diarrhea

Dyspnea (shortness of breath)

Edema: limb

Fatigue (asthenia, lethargy, malaise)

Febrile neutropenia

Hypotension

Hypoxia

Leukocytes (total WBC)

Lymphopenia

Metabolic/Laboratory-Other (Specify)

Mucositis/stomatitis (clinical exam) - Oral cavity

Muscle weakness, not d/t neuropathy - body/general

Nausea

Neutrophils/granulocytes (ANC/AGC)

Ocular/Visual-Other (Specify)

PTT (Partial thromboplastin time)

Pain - Abdomen NOS

Pain - Back

Pain - Cardiac/heart

Pain - Extremity-limb

Pain - Head/headache

Pain - Tumor pain

Prolonged QTc interval

Renal failure

SVT and nodal arrhythmia - Atrial fibrillation

SVT and nodal arrhythmia - Atrial flutter

SVT and nodal arrhythmia - Sinus tachycardia

Sodium, serum-low (hyponatremia)

Somnolence/depressed level of consciousness

Syncope (fainting)

Thrombosis/thrombus/embolism

Vascular-Other (Specify)

Vision-blurred vision

Vomiting

Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.

Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Overall Study

Spots Global Cancer Trial Database for cutaneous nodular melanoma