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Recurrent Adult Hodgkin LymphomaPhase 1NCT01902160

Temsirolimus and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

A Phase 1 study testing Brentuximab Vedotin, Laboratory Biomarker Analysis and Temsirolimus in people with Recurrent Adult Hodgkin Lymphoma, 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 studies the side effects and best dose of temsirolimus when given together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has returned or has not responded to treatment. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Adult Hodgkin Lymphoma
What is being tested?
Brentuximab Vedotin, Laboratory Biomarker Analysis and Temsirolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Sep 2013to May 2015
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

  • Patients must have histologically confirmed cluster of differentiation (CD)30 positive relapsed or refractory Hodgkin lymphoma
  • Measurable disease, defined as at least one lesion > 1.5 cm, in the greatest transverse diameter
  • Patients must have failed autologous stem cell transplant or at least 2 prior cytotoxic regimens for Hodgkin lymphoma
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Life expectancy of greater than 3 months
  • Leukocytes >= 3,000/mcL
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  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin within normal institutional limits or < 3 x the upper limit of normal in patients with Gilbert's disease
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 × institutional upper limit of normal
  • Creatinine =< 1.5 x institutional upper limit of normal OR creatinine clearance >= 40 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Patients must have no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 92% while breathing room air
  • Patients must have forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test (PFT), unless due to large mediastinal mass from Hodgkin's lymphoma (HL); carbon monoxide diffusion capacity (DLCO), FEV1, and FVC all > 50% predicted value
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of temsirolimus and brentuximab vedotin administration
  • Ability to understand and the willingness to sign a written informed consent document
  • Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x upper limit of normal (ULN); NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
  • Patients with known human immunodeficiency virus (HIV) infection must have CD4 count greater than 200; anti-retroviral agents that induce or inhibit cytochrome P450 (CYP)3A4 activity are not allowed

Who cannot join

  • Patients who are eligible for autologous stem cell transplant unless they refuse to receive autologous stem cell transplant
  • Patients who have had chemotherapy or radiotherapy within 3 weeks of registration or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier; Note: patients are considered enrolled on the study after protocol registration and not after signing consent
  • Patients who have received brentuximab vedotin within 6 months of enrolling on the study
  • Patients who are receiving any other investigational agents
  • Patients with known cerebral or meningeal involvement by lymphoma should be excluded from this clinical trial
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to temsirolimus or brentuximab vedotin
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  • Patients receiving any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled diabetes, clinically significant pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with temsirolimus and brentuximab vedotin
  • Previous primary progression or grade 3 toxicity on treatment with brentuximab vedotin
  • Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone =< 20 mg; topical or inhaled corticosteroids are allowed

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase 1 Study of Brentuximab Vedotin in Combination With Temsirolimus in Relapsed and Refractory Hodgkin Lymphoma

This phase I trial studies the side effects and best dose of temsirolimus when given together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has returned or has not responded to treatment. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as brentuximab vedotin, may stimulate the immune system in different ways and stop cancer cells from growing. Giving temsirolimus with brentuximab vedotin may work better in treating patients with Hodgkin lymphoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the maximum tolerated dose (MTD) of temsirolimus in combination with brentuximab vedotin in patients with relapsed and refractory Hodgkin lymphoma.

II. To assess the safety of brentuximab vedotin in combination with temsirolimus in patients with relapsed and refractory Hodgkin lymphoma.

III. To assess the toxicity profile of this regimen in the above patients.

SECONDARY OBJECTIVES:

  1. Determine the overall response rate (ORR) to the combination of brentuximab vedotin and temsirolimus in relapsed and refractory Hodgkin lymphoma.

II. Evaluate the role of inflammatory markers, such as interleukin (IL)-6, IL-1, tumor necrosis factor alpha (TNF alpha), and IL-10, as early predictors of treatment response.

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

Patients receive temsirolimus intravenously (IV) over 30-60 minutes on days 1 and 8 or days 1, 8, and 15 and brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Being tested
Brentuximab Vedotin, Laboratory Biomarker Analysis, Temsirolimus
Medical subject headings
Hodgkin Disease

What participants receive

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

  • Brentuximab VedotinDrug

    Also called ADC SGN-35, Adcetris, Anti-CD30 Antibody-Drug Conjugate SGN-35, Anti-CD30 Monoclonal Antibody-MMAE SGN-35

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • TemsirolimusDrug

    Also called CCI-779, CCI-779 Rapamycin Analog, Cell Cycle Inhibitor 779, Rapamycin Analog

    Given IV

Study groups in NCT01902160
Study groupRoleWhat they receive
Treatment (temsirolimus, brentuximab vedotin)ExperimentalPatients receive temsirolimus IV over 30-60 minutes on days 1 and 8 or days 1, 8, and 15 and brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Brentuximab Vedotin; Other: Laboratory Biomarker Analysis; Drug: Temsirolimus

What is being measured

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

  1. MTD of temsirolimus, determined according to incidence of dose limiting toxicity, graded using the National Cancer Institute Common Terminology Criteria for Adverse v4.0

    Toxicity will be reported using the Cancer Therapy Evaluation Program Adverse Event Reporting System.

    Measured: 21 days

Secondary outcomes (2)

  1. Changes in cytokine levels

    Descriptive statistics will be used to analyze the impact of cytokine levels on treatment response. Mean, standard deviation, median and range will be reported. Logistic regression will be used to evaluate the effects of the levels of serum cytokines/growth factors on treatment response.

    Measured: Baseline to day 1 of course 2

  2. Overall response rate (sum of partial responses and complete responses) using the criteria developed by the International Harmonization Project for response assessment in lymphoma

    Measured: Up to 4 weeks

Timeline

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

  1. First posted18 Jul 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionMay 2015

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01902160
Sponsor's protocol ID
NCI-2013-01273
Other IDs
NCI-2013-01273, 13-044, 13-044, 9467, P30CA008748, U01CA069856
Status last verified
Nov 2015
First submitted
15 Jul 2013
Last updated
9 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Brentuximab Vedotin, Laboratory Biomarker Analysis and Temsirolimus in people with Recurrent Adult Hodgkin Lymphoma, 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 17 inclusion and 11 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 Nov 2015. 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 temsirolimus, determined according to incidence of dose limiting toxicity, graded using the National Cancer Institute Common Terminology Criteria for Adverse v4.0 (time frame: 21 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 NCT01902160.

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 Nov 2015.

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