Pilot Trial of "Chemo-Switch" Regimen to Treat Advanced Melanoma

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00673361
• Collaborator: Bayer (Industry)
• Enrollment: 9
• Arm: 1
• Duration (Months): 22.1

Study Details

Study Description

Brief Summary

This research study is testing the "chemo-switch" strategy in melanoma, using biochemotherapy initially to shrink tumors and then switching to daily low-dose chemotherapy (temozolomide) together with sorafenib. The purpose of this study is to find out what effects (good and bad) biochemotherapy followed by temozolomide plus sorafenib have on melanoma.

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Drug: Concurrent decrescendo biochemotherapy regimen; Drug: Low-dose Temozolomide plus Sorafenib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Pilot Trial of "Chemo-Switch" Regimen of Biochemotherapy Followed by Daily Low-Dose Temozolomide Plus Sorafenib in Advanced Melanoma
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm

Intervention/Treatment

Experimental: "Chemo-Switch" Regimen

Drug: Concurrent decrescendo biochemotherapy regimen; Temozolomide: 200mg/m^2, daily, PO, days 1-4 Vinblastine: 1.5mg/m^2, daily, IV, days 1-4 Cisplatin: 20mg/m^2, daily IV, days 1-4 IL (interleukin)-2: - 18 milli-International unit (MIU)/m^2, IVCI (intravenous continual infusion), day 1 9 MIU/m^2, IVCI, day 2 4.5 MIU/m^2, IVCI, days 3 & 4 Interferon (IFN) alpha: 5 MIU/m^2, daily, SC (subcutaneously), days 1-5 5-day inpatient regimen, to be repeated every 21 days; Drug: Low-dose Temozolomide plus Sorafenib; Temozolomide: 75mg/m^2, PO, QD (quaque die), 6 weeks on/2 weeks off Sorafenib: 400mg, PO, BID, 8 weeks

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [3 weeks, 6 weeks, 16 weeks, & 24 weeks]

   Terminated study before accrual goal, no data analysis

Secondary Outcome Measures

1. Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria [post-cycle 1 of low-dose temozolomide plus sorafenib, then every 3 months for up to 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must have histologically or cytologically confirmed melanoma that is locally advanced or metastatic. Cutaneous, mucosal, ocular, and unknown primary melanoma are all eligible.

• Must have measurable disease, defined by RECIST as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as

20mm with conventional techniques or >10mm with spiral CT scan.

• May have received prior radiation therapy to one or more non-index lesions (prior radiation to an index lesion is allowable only if progression of the irradiated lesion is demonstrated, with progression defined as an increase of 20% or more in the largest diameter) and/or one prior vaccine therapy for metastatic disease. Prior adjuvant therapy with IFN alpha-2b, vaccine, and/or granulocyte-macrophage colony-stimulating factor (GM-CSF) is permitted. At least 4 weks must have elapsed since the completion of any prior therapy.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Patients must have normal organ and marrow function as defined below:

• leukocytes >3,000/uL (microliters)

• absolute neutrophil count >1,500/uL

• platelets >100,000/uL

• total bilirubin <2.0mg/dL

• AST (Aspartate transaminase)(SGOT)/ALT (Alanine transaminase)(SGPT) <2.5 X institutional upper limit of normal

• creatinine <1.8mg/dL

• If >50 years of age with one or more cardiac risk factors, must demonstrate normal exercise stress test, stress thallium test, or comparable cardiac ischemia evaluation.

• Must be at least 2 weeks out from major surgery and be free of any active infection requiring antibiotics.

• Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Women must demonstrate a negative pregnancy test prior to initiation of protocol therapy.

• Ability to understand and the willingness to sign a written informed consent form.

Exclusion Criteria:

• Prior chemotherapy, cytokine therapy (including IL-2 or IFN alpha), or antibody therapy for metastatic disease. Prior vaccine therapy is permitted.

• May not be currently receiving any other antineoplastic treatments, including chemotherapy, biologic response modifiers, radiation, vaccine, or investigational agents.

• History of brain metastases.

• Autoimmune disorders that could result in life-threatening complications in the setting of IFN alpha and IL-2 treatment.

• History of sensitivity to E. coli-derived products.

• Concurrent use of corticosteroids or any medical condition likely to require the use of systemic corticosteroids.

• A seizure disorder currently requiring anti-epileptic medication.

• Uncontrolled intercurrent illness including, but not limited to, hypertension, active infection requiring antibiotic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• Evidence of bleeding diathesis.

• Currently on therapeutic anticoagulation. Prophylactic anticoagulation (such as low-dose warfarin) of venous or arterial access devices is allowed provided the PT, PTT (Partial Thromboplastin Time), and international normalized ratio (INR) are normal.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Duke University
• Bayer

Investigators

• Principal Investigator: Michael A Morse, M.D., Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00673361
• Other Study ID Numbers: 9361; SR05-888
• First Posted: May 7, 2008
• Last Update Posted: Jan 13, 2016
• Last Verified: Dec 1, 2012

• Additional relevant MeSH terms: Melanoma; Temozolomide; Sorafenib

Study Results

Participant Flow

Arm/Group Title	"Chemo-Switch" Regimen
Arm/Group Description
Period Title: Overall Study
STARTED	9
COMPLETED	7
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	"Chemo-Switch" Regimen
Arm/Group Description
Overall Participants	9
Age, Customized (participants) [Number]
Number [participants]	9 100%
Sex: Female, Male (Count of Participants)
Female	5 55.6%
Male	4 44.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 22.2%
White	7 77.8%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	9 100%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival (PFS)
Description	Terminated study before accrual goal, no data analysis
Time Frame	3 weeks, 6 weeks, 16 weeks, & 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Terminated Studybefore Accrual Goal
Arm/Group Description
Measure Participants	0

2. Secondary Outcome

Title	Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Time Frame	post-cycle 1 of low-dose temozolomide plus sorafenib, then every 3 months for up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	"Chemo-Switch" Regimen
Arm/Group Description
All Cause Mortality
	"Chemo-Switch" Regimen
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	"Chemo-Switch" Regimen
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Other (Not Including Serious) Adverse Events
	"Chemo-Switch" Regimen
	Affected / at Risk (%)	# Events
Total	0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.