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Recurrent MelanomaPhase 1NCT00112476

Temsirolimus and Bryostatin 1 in Treating Patients With Unresectable or Metastatic Solid Tumors

A Phase 1 study testing bryostatin 1 and temsirolimus in people with Recurrent Melanoma and Recurrent Renal Cell Cancer, run by National Cancer Institute (NCI) at 1 site 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

This phase I trial is studying the side effects and best dose of temsirolimus when given together with bryostatin 1 in treating patients with unresectable or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bryostatin 1 and temsirolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Mar 2005to Jul 2010
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

  • Histologically confirmed solid tumor, including melanoma or renal cell carcinoma
  • Metastatic or unresectable disease
  • Must have evidence of residual, recurrent, or metastatic disease by radiography
  • Measurable disease
  • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (CT scan, MRI, or x-ray) OR ≥ 10 mm by spiral CT scan
  • Must show clear evidence of disease progression within the lesion if the only site of measurable disease is within a previously irradiated volume
Show all 47Show fewer
  • Standard curative or palliative measures do not exist OR are no longer effective
  • No history of or known brain metastases
  • Performance status - ECOG 0-1
  • At least 3 months
  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • Creatinine ≤ 1.5 times ULN
  • Creatinine clearance ≥ 50 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Fasting cholesterol ≤ 350 mg/dL*
  • Triglycerides ≤ 400 mg/dL*
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile female patients must use effective contraception for ≥ 1 month before, during, and for ≥ 3 months after completion of study treatment (during and for ≥ 3 months after completion of study treatment for male patients)
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
  • No ongoing or active bacterial or viral infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No dementia or altered mental status that would preclude giving informed consent
  • No other uncontrolled illnesses
  • More than 3 weeks since prior immunotherapy
  • Prior biological therapy (e.g., interferon or interleukin 2, vaccine, antibody-based and tyrosine kinase inhibitors) allowed
  • No concurrent prophylactic hematopoietic colony-stimulating factors except for epoetin alfa
  • No prior cytotoxic chemotherapy
  • No prior bryostatin 1, temsirolimus, everolimus, or AP23573 for this malignancy
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No concurrent steroids except for topical or inhaled use
  • No other concurrent experimental agents
  • No prior radiotherapy to > 25% of bone marrow
  • More than 3 weeks since prior radiotherapy
  • More than 3 weeks since prior major surgery, including nephrectomy
  • Minor surgical procedures allowed
  • Recovered from prior therapy
  • More than 3 weeks since prior other anticancer investigational agents
  • Concurrent CYP3A4 inducers or inhibitors allowed provided patient has been on a stable dose for ≥ 1 week before study entry
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent antineoplastic agents or therapies

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

Other trials in United States

About this study

Official title: A Phase I Study of Intravenous CCI-779 in Combination With Bryostatin-1 in Solid Tumors (10038414)

This phase I trial is studying the side effects and best dose of temsirolimus when given together with bryostatin 1 in treating patients with unresectable or metastatic solid tumors. Drugs used in chemotherapy, such as temsirolimus and bryostatin 1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the maximum tolerated dose and recommended phase II dose of temsirolimus when given together with bryostatin 1 in patients with unresectable or metastatic solid tumors.

II. Determine the dose-limiting toxic effects of this regimen in these patients.

SECONDARY OBJECTIVES:

  1. Correlate the extent and duration of inhibition of p70^S6kinase phosphorylation in peripheral blood mononuclear cells with tumor growth or reduction in these patients.

II. Correlate the phosphorylation total and phospho-AKT and total and phospho ribosomal S6 protein (indicators of mTOR activation) with antitumor effects of this regimen in these patients.

III. Correlate tumor expression of phospho-ERK1 and -ERK2 with antitumor effects of this regimen in these patients.

IV. Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation study of temsirolimus.

Patients receive bryostatin 1 IV over 1 hour on days 1, 8, 15, and 22 and temsirolimus IV over 30 minutes once on days 8, 15, and 22 during course 1. On subsequent courses patients receive bryostatin 1 and temsirolimus once on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Being tested
bryostatin 1, temsirolimus
Medical subject headings
Melanoma, Carcinoma, Renal Cell

What participants receive

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

  • bryostatin 1Drug

    Also called B705008K112, BRYO, Bryostatin

    Given IV

  • temsirolimusDrug

    Also called CCI-779, cell cycle inhibitor 779, Torisel

    Given IV

Study groups in NCT00112476
Study groupRoleWhat they receive
Treatment (bryostatin, temsirolimus)ExperimentalPatients receive bryostatin 1 IV over 1 hour on days 1, 8, 15, and 22 and temsirolimus IV over 30 minutes once on days 8, 15, and 22 during course 1. On subsequent courses patients receive bryostatin 1 and temsirolimus once on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: bryostatin 1; Drug: temsirolimus

What is being measured

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

  1. MTD of CCI-779 and Bryostatin-1 administered in combination, graded according to NCI Common Toxicity Criteria, Version 3.0

    A dose-limiting toxicity is defined as a toxicity that is >= grade 3 and drug-related.

    Measured: 28 days

Secondary outcomes (2)

  1. Changes in sum of RECIST measurements

    Measured: Baseline up to 30 days after completion of study treatment

  2. AKT activity, measured by immunohistochemistry (IHC), classified as none, weak, moderate, or strong

    Measured: Up to 30 days after completion of study treatment

Timeline

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

  1. First posted3 Jun 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionJul 2010

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00112476
Sponsor's protocol ID
NCI-2011-01382
Other IDs
04-037, FCCC-04037, NCI-5785, CDR0000432955
Status last verified
May 2013
First submitted
2 Jun 2005
Last updated
3 May 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing bryostatin 1 and temsirolimus in people with Recurrent Melanoma and Recurrent Renal Cell Cancer, run by National Cancer Institute (NCI) at 1 site 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 47 inclusion and 0 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 3 May 2013. 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 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?

MTD of CCI-779 and Bryostatin-1 administered in combination, graded according to NCI Common Toxicity Criteria, Version 3.0 (time frame: 28 days). 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 NCT00112476.

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 3 May 2013.

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