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Advanced MelanomaPhase 1/2NCT01614301

Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial in Patients With Advanced Melanoma

A Phase 1/2 study testing dacarbazine (DTIC), Trofosfamide, Etoricoxib, Pioglitazone, Temsirolimus in people with Advanced Melanoma, run by University of Regensburg at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A prospective phase I and consecutive phase II, twoarm, randomized multi-center trial of temsirolimus in combination with pioglitazone, etoricoxib and metronomic low-dose trofosfamide versus dacarbazine (DTIC) in patients with advanced melanoma Phase I: To determine the dose of temsirolimus to be used in phase II part… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Melanoma
What is being tested?
dacarbazine (DTIC), Trofosfamide, Etoricoxib, Pioglitazone, Temsirolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteGermany
Study dates
May 2012to May 2016
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

  • At least 18 years of age
  • Must be able to adhere to the study visit schedule and other protocol requirements.
  • Must be histologically diagnosed with metastatic melanoma and LDH level > 0.8 ULN
  • Measurable lesions
  • Subjects must receive study medication as first-line therapy. Preceeding adjuvant therapies are allowed.
  • BRAF V600 mutation analysis
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  • Sufficient bone marrow function: neutrophils ≥ 2x109/l, hemoglobin ≥10 g/dl, platelets ≥ 100x109/l
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (see Post Text Supplement 3).
  • Required laboratory results:
  • Liver function: Total bilirubin < 1.5 times of upper limit of local institution (ULN), SGPT, SGOT ≤ 2.5 times of upper limit of local institution
  • Renal function: serum creatinine ≤ 1.5 ULN
  • PT-INR/PT <1.5 ULN
  • Normal cardiac function
  • Patients with prior thrombembolic event with adequate anticoagulation
  • Life expectancy at least 3 months
  • Written informed consent of the patient prior to screening procedures
  • Patient must be available for treatment and follow-up
  • Adequate contraception in women capable of bearing children and men with partner capable of bearing children (combined oral contraceptives, hormonereleasing intrauterine contraceptive device, hormonal contraceptive implants, hormonal contraceptive injectables, surgical sterilization)
  • Any previous surgery must have taken place more than 4 weeks prior to inclusion
  • Previous radiation therapy must have involved less than 25% of bone marrow, and must have been completed more than 4 weeks prior to inclusion.
  • For patients with controlled diabetes mellitus glucose levels have to be monitored continuously and the treating diabetologist has to be informed about the study participation of the patient.
  • Patients with wild-type BRAF

Who cannot join

  • Documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 4 weeks before enrollment.
  • Patients who require vitamin K antagonists except for low dose
  • Patients with bladder cancer or bladder cancer in their medical history, patients with risk factors for bladder cancer (such as exposure to aromatic amines or heavy tobacco smokers), or macrohematuria of unknown origin
  • Prior history of stroke
  • Known hypersensitivity to study drugs or to any of the excipients
  • Active infection > grade 2 NCI-CTC version 4.0
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  • Known diagnosis of HIV, hepatitis B, or hepatitis C infection.
  • Severe, unstable, or uncontrolled medical disease which would confound diagnoses or evaluations required by the protocol, including cardiac insufficiency (NYHA I -IV) uncontrolled diabetes including diabetic ketoacidosis, chronic hepatic or renal disease, active uncontrolled infection and chronic inflammatory intestinal disease, autoimmune diseases, peripheral arterial disease, verified coronary heart disease, cerebrovascular disease, acute peptic ulcer or acute gastro-intestinal bleeding.
  • Prior radiation therapy > 25% of bone marrow
  • Regular blood transfusions
  • Treatment with other experimental substances within 30 days before study start
  • Prior immunotherapy with ipilimumab, vaccination, B-raf inhibitor
  • Participation in another clinical trial within 30 days before study start or during the trial
  • Unwilling or unable to comply with the protocol
  • Pregnant or breastfeeding patients. Women of childbearing potential must have a negative pregnancy test performed 7 days prior start of treatment.
  • Patients with seizure disorders requiring medication (such as steroids or antiepileptics)
  • Patients with evidence or history of bleeding diathesis
  • Patients undergoing renal dialysis
  • Major surgery within 4 weeks prior to start of study or incomplete wound healing
  • Drug or alcohol abuse
  • Psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results.
  • Known (at time of entry) gastrointestinal disorder, including malabsorbtion or active gastric ulcer, present to the extent that it might interfere with oral intake and absorption of study medication
  • Patients undergoing dialysis or creatinine clearance <30 mL per minute, defined according to MDRD
  • Patients with medically uncontrolled hypertension (RR continuously > 140/90 mm Hg)
  • Any previous or concurrent malignancy or any cancer unless curatively treated > 3 years prior to study entry except cervical carcinoma in situ or adequate basal cell carcinoma
  • Any urothelial cell carcinoma in the medical history
  • Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic type reactions after acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors
  • Patients with BRAF V600 mutant metastatic melanoma

Trial locations and contacts

1 site in 1 country.

Germany1 site, 1 recruiting

  • University of Regensburg

    Regensburg, Bavaria, 93053

    Albrecht Reichle, Professor, +499419440, albrecht.reichle@UKR.de

    Martin Vogelhuber, MD

    Recruiting

Other trials in Germany

About this study

Official title: A Prospective Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial of Temsirolimus in Combination With Pioglitazone, Etoricoxib and Metronomic Low-dose Trofosfamide Versus Dacarbazine (DTIC) in Patients With Advanced Melanoma

A prospective phase I and consecutive phase II, twoarm, randomized multi-center trial of temsirolimus in combination with pioglitazone, etoricoxib and metronomic low-dose trofosfamide versus dacarbazine (DTIC) in patients with advanced melanoma

Phase I: To determine the dose of temsirolimus to be used in phase II part of the study

Phase II:

To determine overall survival Secondary objectives

  • To evalulate response rate
  • To evaluate time to progression (TTP)
  • To evalulate time to partial response (time to PR or better)(TPR)
  • To evaluate quality of life
  • To evaluate tolerability and safety
Being tested
dacarbazine (DTIC), Trofosfamide, Etoricoxib, Pioglitazone, Temsirolimus
Keywords
advanced Melanoma

What participants receive

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

  • dacarbazine (DTIC), Trofosfamide, Etoricoxib, Pioglitazone, TemsirolimusDrug

    Dacarbazine (DTIC) 1000 mg/m2 day 1, every 3 weeks The total number of DTIC cycles should not exceed 6 cycles due to cumulative toxicity.

    Temsirolimus: 15 or 25 mg iv weekly , week 1+.In the phase I part of the study the finally used dosis will be determined. Pioglitazone (Actos) 60 mg p.o. daily, day 1+. Etoricoxib (Arcoxia) 60 mg p.o. daily, day 1+. Trofosfamide (Ixoten) 50 mg p.o. thrice daily as metronomic angiostatically and immunomodulatory actingtherapy, day 1+. Treatment until disease progression or toxicity

Study groups in NCT01614301
Study groupRoleWhat they receive
Experimental ArmExperimentalTemsirolimus: 15 or 25 mg iv weekly , week 1+.In the phase I part of the study the finally used dosis will be determined. Pioglitazone (Actos) 60 mg p.o. daily, day 1+. Etoricoxib (Arcoxia) 60 mg p.o. daily, day 1+ Trofosfamide (Ixoten) 50 mg p.o. thrice daily as metronomic angiostatically and immunomodulatory acting therapy, day 1+. Treatment until disease progression or toxicity
Receives: Drug: dacarbazine (DTIC), Trofosfamide, Etoricoxib, Pioglitazone, Temsirolimus
Controll ArmOtherDacarbazine (DTIC) 1000 mg/m2 day 1, every 3 weeks. The total number of DTIC cycles should not exceed 6 cycles due to cumulative toxicity.
Receives: Drug: dacarbazine (DTIC), Trofosfamide, Etoricoxib, Pioglitazone, Temsirolimus

What is being measured

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

  1. response rate

    Measured: 2014

Secondary outcomes (1)

  1. Time to progession

    Measured: 2014

Timeline

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

  1. First posted7 Jun 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionMay 2014 (estimated)
  4. Study completionMay 2016 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01614301
Sponsor's protocol ID
MEL001
Status last verified
Jun 2012
First submitted
5 Jun 2012
Last updated
7 Jun 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing dacarbazine (DTIC), Trofosfamide, Etoricoxib, Pioglitazone, Temsirolimus in people with Advanced Melanoma, run by University of Regensburg at 1 site in Germany.

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 22 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

response rate (time frame: 2014). 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 NCT01614301.

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 7 Jun 2012.

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