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Metastatic MelanomaPhase 1/2NCT02065466

Combo of Abraxane, TMZ, Bevacizumab in Metastatic Melanoma With Brain Metastases

A Phase 1/2 study testing nab-paclitaxel, Temozolomide and Bevacizumab in people with Metastatic Melanoma and Brain Metastases, run by University of Arizona at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

1.1. Primary Objectives 1. To determine if nab-paclitaxel and temozolomide can be combined with full dose of bevacizumab for the therapy of patients with newly diagnosed brain metastases of metastatic malignant melanoma. To define the MTD of the combination (Phase I component). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma, Brain Metastases
What is being tested?
nab-paclitaxel, Temozolomide and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
Jul 2014to Aug 2015
Phase
Phase 1/2
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

  • Histologically or cytologically confirmed malignant melanoma and clinical evidence of metastatic disease to the brain. Mucosal and ocular melanomas are included.
  • Newly developed inoperable brain metastases without associated hemorrhage or midline shift.
  • Inoperable or metastatic extra cranial stage III or IV disease.
  • Diagnostic quality MRI of the brain or if contraindicated then contrast CT scan of the head performed within 28 days prior to registration.
  • Measurable metastases to the brain, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm in the brain MRI/CT scan.
  • CT scan chest, abdomen and pelvis or PET CT scan performed within 28 days of study registration. For disease outside the brain, tumors must be > 10 mm by CT scan.
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  • Prior therapy allowed but no prior therapy with nab-paclitaxel, paclitaxel, temozolomide, DTIC or bevacizumab.
  • Bevacizumab may not be initiated until 4 weeks after surgical resection or radiation therapy completion.
  • Age 18 or older.
  • Pre-existing peripheral neuropathy must have < Grade 2 (per CTCAE 4.0) at the time of registration.
  • Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential.
  • Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment.
  • ECOG Performance status 0-1.
  • Estimated life expectancy of greater than 2 months.
  • Patients must have adequate organ function as defined below (these must be evaluated within 14 days prior to registration):
  • leukocytes >3,000/mcL
  • absolute neutrophil count >1,500/mcL
  • platelets >100,000/mcL
  • Hemoglobin >9.0 g/dL
  • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit
  • Alkaline phosphatase <2.5 X institutional upper limit
  • Total bilirubin <1.5 X institutional upper limit of normal (unless associated with Gilbert's syndrome)
  • serum creatinine < 1.5 mg/dL OR 1.5 x institutional normal
  • LDH there is no restriction
  • INR <1.5 PTT WNL
  • Urine protein (UPC) ratio 1.0 OR
  • Urine dipstick for proteinuria. Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
  • Able to render informed consent.

Who cannot join

  • Prior surgical resection for brain metastases.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, nab-paclitaxel or temozolomide.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, unstable angina pectoris, untreated cardiac arrhythmia and peripheral vascular disease.
  • History of myocardial infarction or unstable angina within 6 months prior to Day 1.
  • History of stroke or transient ischemic attack within 6 months prior to Day 1.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study screening.
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  • Serious, non-healed wound, ulcer, or bone fracture.
  • History of hepatitis B, C or HIV.
  • Uncontrolled hypertension or chronic renal disease. No known bleeding diathesis.
  • Known hypersensitivity to human albumin.
  • Surgery within 4 weeks of study registration. Must be fully recovered and fully healed from any prior surgery.
  • Patients having chemotherapy or extra cranial radiotherapy within 4 weeks prior to study screening or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to the completion of study screening.
  • Evidence of other concurrent active malignancy.
  • Pregnant or nursing.
  • Not be receiving any other investigational agent.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724-5024

  • University of Arizona Cancer Center

    Tucson, Arizona, 85742

Other trials in United States

About this study

Official title: A Pilot Study of the Combination of Nab-paclitaxel, Temozolomide and Bevacizumab in Patients With Metastatic Melanoma With Brain Metastases

1.1. Primary Objectives

  1. To determine if nab-paclitaxel and temozolomide can be combined with full dose of bevacizumab for the therapy of patients with newly diagnosed brain metastases of metastatic malignant melanoma.
Read more
  • To define the MTD of the combination (Phase I component).
  • To determine progression free survival (Phase II component). 1.2. Secondary Objectives
  1. To separately evaluate the response rate and duration of both the brain and extra-cranial systemic metastases.
  2. To define the toxicity of the regimen.
  3. To tabulate the toxicity of the radiotherapy to the brain and compare with known toxicities of radiotherapy to the brain in melanoma and brain metastases.
  4. To use the data generated to plan definitive controlled clinical trials of the combination.
  5. To determine the overall response rate (Phase II component).
Medical subject headings
Melanoma, Brain Neoplasms

What participants receive

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

Study groups in NCT02065466
Study groupRoleWhat they receive
CombinationExperimentalnab-paclitaxel and temozolomide combined with full dose of bevacizumab
Receives: Drug: nab-paclitaxel; Drug: Temozolomide; Drug: Bevacizumab

What is being measured

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

  1. Maximum Tolerance Dose

    To define the MTD of the combination (Phase I component).

    Measured: Beginning of Treatment to unstable disease or discontinuation (6 months)

  2. Progression Free Survival

    To determine progression free survival (Phase II component).

    Measured: Treatment to End of Follow-up (6 Months)

Secondary outcomes (1)

  1. Response Rate

    To determine the overall response rate (Phase II component).

    Measured: Baseline to end of follow-up (six months)

Timeline

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

  1. First posted19 Feb 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionFeb 2015
  4. Study completionAug 2015

Why it stopped: lack of accrual

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02065466
Sponsor's protocol ID
1312169092
Status last verified
Apr 2016
First submitted
6 Feb 2014
Last updated
21 Apr 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing nab-paclitaxel, Temozolomide and Bevacizumab in people with Metastatic Melanoma and Brain Metastases, run by University of Arizona at 2 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 28 inclusion and 15 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: withdrawn, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Maximum Tolerance Dose (time frame: Beginning of Treatment to unstable disease or discontinuation (6 months)). The study lists 2 primary outcomes in all. 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 NCT02065466.

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 21 Apr 2016.

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