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MelanomaPhase 1NCT01127594

Evaluate Safety/Tolerability Intra-Arterial Temozolomide in Patients w/Extremity Melanoma by Isolated Limb Infusion

A Phase 1 study testing Temozolomide in people with Melanoma, run by Douglas Tyler at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the safety profile of intra-arterial temozolomide administration during Isolated Limb Infusion (ILI) by defining the dose limiting toxicities associated with this treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Temozolomide
How many people
29 participants
Where
3 sitesUnited States
Study dates
Jul 2010to Jun 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must have undergone a previous Melphalan based regional therapy for which they did not respond optimally and present with persistent, progressive, or recurrent disease.
  • Patient must be 18 years of age or older.
  • Patient must have an ECOG status of 0-1.
  • Patient must have histologically proven primary or recurrent extremity melanoma, stage IIIB, IIIC, or IV
  • Patients with Stage IIIC disease must either have had regional lymph nodes previously removed or will have them removed at the time of regional treatment.
  • Patients with Stage IV disease must have had all distant disease resected at least 30 days prior to regional treatment.
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  • Disease to be treated by ILI must be distal to the planned site of tourniquet placement
  • Patient's disease must be bi-dimensionally measurable by caliper or radiological method as defined in the RECIST criteria.
  • Patient must have adequate bone marrow, liver and renal function
  • Patient must have a palpable femoral/radial pulse in the affected extremity.
  • Recovery from relevant toxicity prior to first study drug administration.
  • Patients must have a life expectancy of > 6 months.
  • Ability to read and understand English and the ability to complete paper +/- electronic survey assessments.

Who cannot join

  • Cardiac disease: Congestive heart failure > class II NYHA.
  • Known brain metastasis.
  • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
  • Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
  • Active clinically serious infection > CTCAE Grade 2.
  • Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
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  • Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of administration of TMZ
  • Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of administration of TMZ.
  • Serious non-healing wound, ulcer, or bone fracture.
  • Major surgery or significant traumatic injury within 30 days of ILI.
  • Evidence or history of bleeding diathesis or coagulopathy.
  • Antineoplastic therapy, radiotherapy, or any other investigational drug within 30 days prior to first study drug administration.
  • Patients with symptoms or signs of vascular insufficiency. Specifically, patients with any history of blood clots or lifestyle altering ischemic peripheral vascular disease will be excluded.
  • History of allergic reactions and/or hypersensitivity to TMZ.
  • Psychiatric conditions or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance.
  • Pregnant or nursing women are not eligible for this study. Patients of reproductive potential must agree to use an effective method of birth control when undergoing treatments with known or possible mutagenic or teratogenic effects. All female participants of child-bearing potential must have a negative serum pregnancy test within two weeks of patient registration. Please note: use of contraception, including surgical procedures such as vasectomy or tubal ligation DO NOT eliminate the need for administering pregnancy testing.
  • Current treatment, or treatment in the previous 24 months, for another non-melanoma malignancy.
  • Unable to return at the regular required intervals for reassessment, or study drug administration.
  • Patients with known heparin induced thrombocytopenia.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Multi-Center Phase I Dose Escalation Trial to Evaluate Safety and Tolerability of Intra-Arterial Temozolomide for Patients With Advanced Extremity Melanoma Using Normothermic Isolated Limb Infusion

The purpose of this study is to determine the safety profile of intra-arterial temozolomide administration during Isolated Limb Infusion (ILI) by defining the dose limiting toxicities associated with this treatment. This study also aims to determine the maximum tolerated dose of intra-arterial administration of temozolomide during ILI that will be used in a phase II trial.

Read the detailed description
  1. The primary objective of this study is to determine the safety profile of intra-arterial temozolomide administration during Isolated Limb Infusion (ILI) by defining the dose limiting toxicities associated with this treatment and to determine the maximum tolerated dose of intra-arterial administration of temozolomide during ILI that will be used in a phase II efficacy trial.
  2. Population will include patients who have undergone a previous Melphalan based regional therapy for which they did not respond optimally and present with persistent, progressive, or recurrent disease. Study activities include tumor tissue sampling, blood sampling, and subjects will undergo an Isolated Limb Infusion.
  3. To define both response in-field (area of the limb below the tourniquet) and out-of-field (any area outside the tourniquet) in patients treated with temozolomide based ILI. Response in this trial will be defined by the RECIST criteria (CR, PR, SD, PD at 12 weeks post ILI). A CR rate of 20% would be considered as preliminary evidence of a promising approach in this group of patients that have had a previous melphalan regional treatment. ILI with melphalan has a complete response rate of approximately 35% in naïve patients and 20% in patients who have previously received melphalan based regional therapy.

To assess if the proposed treatment has any effect on quality of life as measured by the Functional Assessment of Cancer Therapy - Melanoma.

Conditions
Melanoma
Being tested
Temozolomide
Keywords
Melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TemozolomideDrug

    Also called Temodar

    Dose level selection will proceed according to the modified Accelerated Titration Design. The starting dose will be TMZ 200mg/m2 x 0.09 BSA for the upper extremity and 200mg/m2 x 0.18 BSA for the lower extremity. We will enroll one-patient cohorts with dose doubling between cohorts until 1st occurrence of a ≥ CTC (Common Terminology Criteria) grade 2 adverse event. At that time, the present cohort and all future cohorts will be extended to enroll 3 to 6 patients.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Profile of intra-arterial temozolomide and maximum tolerated dose of temozolomide

    To determine the safety profile of intra-arterial temozolomide administration during Isolated Limb Infusion (ILI) by defining the dose limiting (DLT) and non dose limiting toxicities associated with this treatment.

    To determine the maximum tolerated dose (MTD) for intra-arterial administration of temozolomide during ILI that will be used in a phase II efficacy trial.

    Measured: 12 Weeks

Secondary outcomes (1)

  1. To define tumor response in field in patients treated with temozolomide

    To define both response in-field (area of the limb below the tourniquet) and out-of-field (any area outside the tourniquet) in patients treated with temozolomide based ILI at the MTD dose. Response in this trial will be defined by the RECIST criteria (CR, PR, SD, PD at 12 weeks post ILI). A CR rate of 20% would be considered as preliminary evidence of a promising approach in this group of patients that have had a previous melphalan regional treatment. To assess if the proposed treatment has any effect on quality of life as measured by the Functional Assessment of Cancer Therapy - Melanoma.

    Measured: Until disease progression or death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionAug 2013
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01127594
Sponsor's protocol ID
Pro00020406
Status last verified
Mar 2015
First submitted
19 May 2010
Last updated
9 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Temozolomide in people with Melanoma, run by Douglas Tyler at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Profile of intra-arterial temozolomide and maximum tolerated dose of temozolomide (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01127594.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.

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