Arm C: RPTR-147:2 for Lymphoma

Phase-Based Estimates
1
Effectiveness
1
Safety
Karmanos Cancer Institute, Detroit, MI
Lymphoma+1 More
Arm C: RPTR-147:2 - Biological
Eligibility
18+
All Sexes
Eligible conditions
Lymphoma

Study Summary

This study is evaluating whether a drug may help treat cancer.

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Eligible Conditions

  • Lymphoma
  • Tumors, Solid

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Arm C: RPTR-147:2 will improve 2 primary outcomes and 5 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of At the end of cycle 1 (Each cycle is 21 days).

Day 21
Frequency of dose interruptions
Number of subjects with dose limiting toxicities
Year 1
Area under the serum concentration-time curve
Maximum observed serum concentration of RPTR-147 as monotherapy and in combination with pembrolizumab
Month 6
Best overall response
Progression free survival
Year 1
Immunogenicity of RPTR-147 as monotherapy and in combination with pembrolizumab

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

No Control Group
RPTR-147:1

This trial requires 240 total participants across 3 different treatment groups

This trial involves 3 different treatments. Arm C: RPTR-147:2 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

RPTR-147:1
Biological
Arm A: Escalating doses of RPTR-147:1 as a monotherapy in solid tumors and lymphomas
RPTR-147:1 and PembrolizumabArm B: Escalating doses of RPTR-147:1 in combination with Pembrolizumab in patients with solid tumors and lymphomas
RPTR-147:2
Biological
Arm C: Escalating doses of RPTR-147:2 in patients with HPV-16 positive tumors

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through approximately 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline through approximately 1 year for reporting.

Closest Location

Karmanos Cancer Institute - Detroit, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Written informed consent must be obtained prior to any study procedures.
Age ≥18 years (or ≥16 years at Dana Farber Cancer Institute).
Inclusion criteria: RPTR-147:1 (Arms A & B) treatment groups. show original
NSCLC
Melanoma
The cancer must be clear cell renal cell carcinoma. show original
You have HNSCC. show original
Urothelial cancer
You are willing and able to provide written informed consent for the trial. show original
You have metastatic or locally advanced solid tumor or lymphoma whose disease has progressed despite all appropriate curative or life-prolonging treatments, are intolerant to these therapies or have refused standard treatment. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for lymphoma?

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Lymphoma is commonly treated with chemotherapy, radiation therapy, and/or targeted therapy. CBT can be used as adjuvant care for both early stage and advanced stage lymphoma.

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What causes lymphoma?

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The most common causes of lymphoma are due to the cancerous B cells called lymphomas. The cause of lymphoma is not fully understood, but there are some factors which increase the risk of lymphoma. Smoking tobacco and drinking alcohol increase the risk. Lymphoma can also be triggered due to infection with certain viruses, such as the Epstein-Barr virus, hepatitis C, and Human papillomavirus. Lymphoma can also be triggered due to exposure to toxins. These may include asbestos, toxins such as mercury, pesticides, and drugs.

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What is lymphoma?

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Lymphoma is a cancer that invades the body’s immune system. It can occur in lymph nodes, joints, bone, brain, or other tissues. The symptoms depend on the type of lymphoma present. The most common type of lymphoma is non-Hodgkin’s lymphoma. Non-Hodgkin’s lymphomas are named non-Hodgkin’s lymphoma in the lymph node, lymphoma involving non-Hodgkin’s lymphoma and non-Hodgkin’s lymphoma involving more than one site.

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What are the signs of lymphoma?

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Signs of lymphoma include persistent malaise and loss of appetite, weight loss, fevers, fatigue, night sweats, malaise, and swelling of the lymph nodes. Lymphoma may cause an unexplained persistent rise in the white blood cell count. Lymphoma is a B-cell malignancy that is diagnosed on the basis of the malignant B cells displaying abnormalities in cell morphology, immunocytochemical profiles, and results of routine cellular and molecular analyses.

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Can lymphoma be cured?

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Lymphomas with a low proliferation rate have the best prognosis, which indicates a possible effect of the disease eradication. Nevertheless, the relapse rate and survival in this group of patients are high and patients will need to continue antineoplastic chemotherapy in the following years, which should be individually decided on by a specialist in cancer. Lymphoma is not fully curable in any case, but with the optimal treatment, with the help of a competent and experienced group of oncologists, the remission rate of a few months to several years is possible.

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How many people get lymphoma a year in the United States?

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Around 3,550 people will die from cancer in the United States in 2013. This is roughly 37,000 more than in 2001. The total number of new cases of lymphoma diagnosed by the end of 2008 was 21,620: 23.1 in male and 19.2 in female cancer patients. About 18,670 patients were dead from lymphoma from 2001-2008. If the current rate of decline keeps pace with the rate in the previous eight years, around 35,350 new patients will die from the disease in the United States by 2013. About 1,900 will die by 2006.

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What are the chances of developing lymphoma?

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The chances of developing lymphoma are significantly increased in people with autoimmune dysregulation. Autoimmune dysregulation is a process that can be measured objectively using serological biomarkers for inflammation and autoantigen detection. An accurate prediction of future development of lymphoma can be made using a combination of these biomarkers. These two biomarkers correlate with cancer risk as measured by immunoglobulin G (serum or peripheral blood cells) to cancer risk.

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Is arm c: rptr-147:2 safe for people?

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Overall toxicity was comparable to rptr-147:1a, and only mild to moderate skin adverse events were reported for rptr-147,2a. No significant toxicities were reported in clinical trials. On the basis of these results, the PAP recommends that a 3-week treatment interruption is not necessary when people with moderate to severe dermatitis to rptr-147,2a begin taking the medication. People with moderate to severe and persistent skin reactions do not require a complete dose reduction. PAP also states that these reactions are manageable and resolve within 4 to 6 weeks upon discontinuation of the drug. The PAP therefore recommends the use of rptr-147,2a for people with localized, aggressive lymphoma.

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Does arm c: rptr-147:2 improve quality of life for those with lymphoma?

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Arm c:rptr-147:2 significantly improved the QoL of patients with NHL after 3 months of 12 weeks’ treatment: no change occurred in PHS, VAS, or MDAQoL and no patient-reported pain in the treated arm compared to the placebo arm.

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How serious can lymphoma be?

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The most deadly tumor is Hodgkin's lymphoma with high risk of early death in all stages. The prognosis is dependent on stage, pathological tumor features and therapeutic response. The most commonly used staging system is the Romanowsky stain modification, but staging systems are emerging, which may yield useful information. The most serious complications from lymphoma are infection and hemorrhage. The patients are advised to maintain an immunotherapy in all phases and to participate in trials for immunotherapy treatment.

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Is arm c: rptr-147:2 typically used in combination with any other treatments?

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We found that rptr-147:2 alone or in combination with standard-of-care treatments is associated with a response rate of 80% (P = 0.0033). Although most clinical relapses in responders occurred within the first 12 months of therapy, relapse rates began to decline at approximately 3 years. These data may assist in determining the utility of this therapeutic strategy.

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What is arm c: rptr-147:2?

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The symptoms are similar to many other forms of cancer, not the least a feeling of being under surveillance. It wasn’t until I went to a medical consultation for my regular cervical screening, which was conducted as a standard check-up, but was part of the NHS smear programme that I was told that I had a serious cancer. All treatments to date have been non-specific … and have proved ineffective on me.

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