Accutane

Property	Information
Drug Name	Isotretinoin (Accutane)
FDA Approval	Yes (for acne treatment)
Used for	Neuroblastoma, severe acne
Clinical Trial Phase	Used in various studies for cancer treatment
Clinical Trial Explanation	Not specified
Common Side Effects	Dry skin, liver problems, increased blood lipid levels, dry mouth, muscle or joint pain, sun sensitivity
OS without	Not specified
OS with	Not specified
PFS without	Not specified
PFS with	Not specified
Usefulness Rating	3
Usefulness Explanation	Not specified
Toxicity Level	3
Toxicity Explanation	Isotretinoin is rated as moderately toxic. While it has common side effects like dry skin and increased blood lipid levels, it has also been associated with severe side effects such as liver problems. This means that while taking Isotretinoin, frequent monitoring of health condition is required. Moreover, the use of this drug must be strictly monitored in pregnant women due to potential severe birth defects.

Notes: Isotretinoin, a retinoid related to vitamin A, controls cell growth by acting on specific nuclear receptors. It's used to treat severe acne and explored for cancer therapy potential, notably in neuroblastoma. It's important to avoid vitamin A supplements during treatment to prevent adverse interactions. Monitoring for liver function and blood lipid levels is advised due to possible side effects.

Links: [St. Jude’s comprehensive guide on isotretinoin](https://together.stjude.org/en-us/about-pediatric-cancer/treatment/medicines/isotretinoin.html)

From Ben Williams Book: Accutane (isotretinoin, 13-cis retinoic acid)

When Temodar has been combined with accutane, a retinoid used for acne treatment (also known as 13-cis-retinoic acid, or isotretinoin), the PFS-6 (for recurrent tumors improved from the 21% historical value of Temodar alone, to 32% (96).

In contrast to the improvement in clinical outcome when accutane was combined with Temodar for recurrent tumors, a clinical trial with newly diagnosed patients that combined Temodar with accutane produced less impressive results (97). Fifty-five evaluable patients used both accutane and low-dosage Temodar during radiation, followed by full-dose Temodar + accutane, and produced a median survival time of only 57 weeks and a two-year survival of 20%, both below the survival rates from the large clinical trial with the same protocol that used Temodar without accutane. A second, retrospective clinical trial in Canada (98) that combined accutane with Temodar with newly diagnosed patients produced a median survival of 15.1 months and a two-year survival of 26.7%, both comparable to when Temodar has been used alone.

Although accutane appears not to improve outcome when added to the standard Temodar protocol, it does seem to have activity as a single agent. A phase II clinical trial

evaluating accutane for recurrent gliomas was conducted at the M. D. Anderson Brain Tumor Center (99). The median survival time was 58 weeks for glioblastoma patients and 34 weeks for grade III gliomas. Aggregated over both tumor types (43 evaluable patients) 3 achieved a partial tumor regression, 7 had minor regressions, and 13 had tumor stabilization. A more complete report, using accutane with 86 glioblastoma patients with recurrent tumors was less impressive (100). Median survival time from the onset of treatment was 25 weeks and PFS-6 was 19%. Accutane now is used at M. D. Anderson as a "maintenance therapy" for patients after initial treatment with radiation or traditional chemotherapy. It also has been used in Germany for patients who have had a complete response to other treatment modalities as a maintenance therapy (101). The major side effects have been dry skin, cracked lips, and headaches, although occasional liver toxicity has also occurred. Increases in blood lipid levels frequently occur, often requiring anti- cholesterol medication such as Lipitor. Accutane also may produce severe birth defects if taken during pregnancy.

Although various data now suggest that accutane should not be combined with chemotherapy (for example, see the discussion below in this chapter entitled A trial of 3 repurposed drugs plus Temodar), a series of studies with various types of cancer, including pancreatic, ovarian, colorectal, and melanoma (although not yet with brain tumors), suggest it can be very effective for patients who get a good response from their initial treatment protocol. This is especially relevant to GBM patients who have clean MRIs either after surgery or after treatment with radiation and chemotherapy. An example of the protocol with ovarian cancer involved 65 patients who received the standard treatment of a taxane and a platinum drug (316). After one year of the standard treatment those receiving a benefit were moved to a maintenance treatment using subcutaneous low-dose IL-2 plus oral 13 cRA at a dose of 0.5 mg/kg. This plan was continued for one year after which frequency of dosing was gradually reduced. Patients receiving this treatment plan had a median PFS of 23 months and a median survival of 53 months. Concomitantly, various measures of immune function (lymphocyte count, NK cell count) were substantially improved and there was a substantial reduction in the level of VEGF, reflecting a reduction in angiogenesis.Property "Has original text" (as page type) with input value "Accutane (isotretinoin, 13-cis retinoic acid)</br></br>When Temodar has been combined with accutane, a retinoid used for acne treatment</br>(also known as 13-cis-retinoic acid, or isotretinoin), the PFS-6 (for recurrent tumors</br>improved from the 21% historical value of Temodar alone, to 32% (96).</br></br>In contrast to the improvement in clinical outcome when accutane was combined with</br>Temodar for recurrent tumors, a clinical trial with newly diagnosed patients that</br>combined Temodar with accutane produced less impressive results (97). Fifty-five</br>evaluable patients used both accutane and low-dosage Temodar during radiation,</br>followed by full-dose Temodar + accutane, and produced a median survival time of only</br>57 weeks and a two-year survival of 20%, both below the survival rates from the large</br>clinical trial with the same protocol that used Temodar without accutane. A second,</br>retrospective clinical trial in Canada (98) that combined accutane with Temodar with</br>newly diagnosed patients produced a median survival of 15.1 months and a two-year</br>survival of 26.7%, both comparable to when Temodar has been used alone.</br></br>Although accutane appears not to improve outcome when added to the standard Temodar</br>protocol, it does seem to have activity as a single agent. A phase II clinical trial</br></br>evaluating accutane for recurrent gliomas was conducted at the M. D. Anderson Brain</br>Tumor Center (99). The median survival time was 58 weeks for glioblastoma patients and</br>34 weeks for grade III gliomas. Aggregated over both tumor types (43 evaluable patients)</br>3 achieved a partial tumor regression, 7 had minor regressions, and 13 had tumor</br>stabilization. A more complete report, using accutane with 86 glioblastoma patients with</br>recurrent tumors was less impressive (100). Median survival time from the onset of</br>treatment was 25 weeks and PFS-6 was 19%. Accutane now is used at M. D. Anderson as</br>a "maintenance therapy" for patients after initial treatment with radiation or traditional</br>chemotherapy. It also has been used in Germany for patients who have had a complete</br>response to other treatment modalities as a maintenance therapy (101). The major side</br>effects have been dry skin, cracked lips, and headaches, although occasional liver toxicity</br>has also occurred. Increases in blood lipid levels frequently occur, often requiring anti-</br>cholesterol medication such as Lipitor. Accutane also may produce severe birth defects if</br>taken during pregnancy.</br></br>Although various data now suggest that accutane should not be combined with</br>chemotherapy (for example, see the discussion below in this chapter entitled A trial of 3</br>repurposed drugs plus Temodar), a series of studies with various types of cancer,</br>including pancreatic, ovarian, colorectal, and melanoma (although not yet with brain</br>tumors), suggest it can be very effective for patients who get a good response from their</br>initial treatment protocol. This is especially relevant to GBM patients who have clean</br>MRIs either after surgery or after treatment with radiation and chemotherapy. An</br>example of the protocol with ovarian cancer involved 65 patients who received the</br>standard treatment of a taxane and a platinum drug (316). After one year of the</br>standard treatment those receiving a benefit were moved to a maintenance treatment</br>using subcutaneous low-dose IL-2 plus oral 13 cRA at a dose of 0.5 mg/kg. This plan was</br>continued for one year after which frequency of dosing was gradually reduced. Patients</br>receiving this treatment plan had a median PFS of 23 months and a median survival of 53</br>months. Concomitantly, various measures of immune function (lymphocyte count, NK</br>cell count) were substantially improved and there was a substantial reduction in the level</br>of VEGF, reflecting a reduction in angiogenesis." contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process.

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